(414 days)
The Sterile Hypodermic Syringe for Single Use with/without need for medical purposes to inject fluid into or withdraw fluid from body.
The sterile insulin syringe for single use with needle, with the callbration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.
The sterile insulin syringe for single use with needle, with the callbration unit of insulin for U-40 is a device intended for medical purposes for the manual aspiration of insulin and for the injection of insulin into parts of the body below the surface skin.
The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
-
Disposable Sterile Syringe, with/without needle; luer/luer-lock: Piston, Plunger, Barrel. EO Sterilized. Prescription use. Single use. The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient. Length 83-152mm, Diameter 50-31mm, Tip type luer/luer-lock, Needle tip configuration long bevel angle, Nozzle type Luer / Lock, 6% conical, 1,2 mm, Barrel marking specs 0.01ml-0.5ml, Graduation legibility Legible, Needle cover color Transparent, Lubricant composition Dimethicone, Barrel transparency Transparent/ UV resistant, Needle cover strength 15N (min. 2N max. 15N), Hub/needle bond strength min. 22-69 N. Complied with ISO 7886-1, ISO 7864, ISO 9626. Volume 1mL, 2mL, 2.5mL, 3mL, 5mL, 10mL, 20mL, 25mL, 30mL, 50mL. Sizes 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G. Needle Lengths 13-38 mm. Piston material Isoprene Rubber, Barrel material PP, Plunger material PP, Needle material PP, SUS304. SAL 10-6. Endotoxin Limit 20 EU per device. Biocompatibility Complied with ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization Acute Systemic Toxicity, Hemolytical effect).
-
Sterile Insulin Syringe for Single use, with needle: Needle Cap, Needle, Piston, Plunger, Barrel, End Cap. EO Sterilized. Prescription use. Single use. The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient. Complied with ISO 8537. Volume 0.5ml, 1ml volumes with fixed needle. Needle Lengths 8mm. Piston material Isoprene Rubber, Barrel material PP, Plunger material PP, Needle material SUS304, Needle Cap material PE, End Cap material PE. SAL 10-6. Endotoxin Limit 20 EU per device. Biocompatibility ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization Acute Systemic Toxicity, Subchronic Toxicity, Hemolytical effect).
-
Sterile Hypodermic needle for Single use: Protective cap, Needle, Adhesives, Needle hub. EO Sterilized. Prescription use. Medical professionals and trained care givers. Protective cap, Needle, Adhesives, Needle hub. Single use. For Manual Use Only, For Single Use only. Complied with: ISO 7864, ISO 9626. Sizes 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 30G. Needle Lengths 13-38 mm. Protective cap materials PP, Adhesive Epoxy resin, Needle Hub materials PP, Needle material SUS304. SAL 10-6. Endotoxin Limit 20 EU per device. Biocompatibility Complied with ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization Acute Systemic Toxicity, Hemolytical effect).
The provided text is a 510(k) summary for medical devices (syringes and needles). It does not describe a study involving an AI model or a device that uses AI. Instead, it focuses on demonstrating substantial equivalence of the submitted devices to a predicate device through performance testing against established international standards for medical devices.
Therefore, the requested information regarding acceptance criteria and a study proving an AI device meets those criteria cannot be extracted from this document. The document primarily details the physical and performance specifications of the syringes and needles themselves.
To directly answer your request based on the provided document, I must state that the information related to AI model acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and training set details are not present in the provided text. The document describes a traditional medical device submission, not an AI/ML-enabled medical device.
However, I can extract the acceptance criteria and performance data for the physical medical devices described:
Acceptance Criteria and Device Performance for Physical Medical Devices
The acceptance criteria for these devices are defined by compliance with a series of international ISO standards and USP guidelines. The "device performance" is reported as having "complied with" these standards. No specific quantitative performance metrics (e.g., accuracy, precision, etc.) are provided in a numerical table format for an AI algorithm, as this is not an AI device.
Table of Acceptance Criteria and Reported Device Performance
| Category/Standard | Acceptance Criteria (defined by standard) | Reported Device Performance |
|---|---|---|
| Disposable Sterile Syringe, with/without needle; luer/luer-lock | ||
| ISO 9626 (Stainless steel needle tubing) | Requirements and test methods for needle tubing | Complied with |
| ISO 7886-1 (Sterile hypodermic syringes for manual use) | Requirements and test methods | Complied with |
| ISO 7864 (Sterile hypodermic needles for single use) | Requirements and test methods | Complied with |
| ISO 80369-7 (Small-bore connectors) | Requirements for connectors | Complied with |
| ISO 10993-4 (Biological evaluation - Blood interaction) | Selection of Tests for Interactions with Blood | Complied with, Hemocompatibility carried out |
| ISO 10993-5 (Biological evaluation - Cytotoxicity) | Tests for In Vitro Cytotoxicity | Complied with, Cytotoxicity carried out |
| ISO 10993-10 (Biological evaluation - Irritation/Sensitization) | Tests for Irritation and Skin Sensitization | Complied with, Irritation and Sensitization carried out |
| ISO 10993-11 (Biological evaluation - Systemic Toxicity) | Tests for Systemic Toxicity | Complied with, Acute Systemic Toxicity carried out |
| USP 788 (Particulate Matter in Injections) | Requirements for particulate matter | Complied with |
| ISO 10993-7 (Biological evaluation - EO residuals) | Requirements for Ethylene oxide sterilization residuals | Complied with |
| ISO 10993-12 (Biological evaluation - Sample prep) | Sample preparation and reference materials | Complied with |
| ISO 11135 (EO Sterilization) | Requirements for sterilization process | Complied with |
| ISO 11607-2 (Packaging for sterilized devices) | Validation requirements for packaging | Complied with |
| SAL (Sterility Assurance Level) | 10-6 | Met (Reported in Device Description) |
| Endotoxin Limit | 20 EU per device | Met (Reported in Device Description) |
| Sterile Insulin Syringe for Single use, with needle | ||
| ISO 8537 (Sterile single-use syringes for insulin) | Requirements and test methods | Complied with |
| ISO 10993-4 (Biological evaluation - Blood interaction) | Selection of Tests for Interactions with Blood | Complied with, Hemocompatibility carried out |
| ISO 10993-5 (Biological evaluation - Cytotoxicity) | Tests for In Vitro Cytotoxicity | Complied with, Cytotoxicity carried out |
| ISO 10993-10 (Biological evaluation - Irritation/Sensitization) | Tests for Irritation and Skin Sensitization | Complied with, Irritation and Sensitization carried out |
| ISO 10993-11 (Biological evaluation - Systemic Toxicity) | Tests for Systemic Toxicity | Complied with, Acute Systemic Toxicity, Sub-acute Systemic Toxicity, Sub-chronic Systemic Toxicity carried out |
| USP 788 (Particulate Matter in Injections) | Requirements for particulate matter | Complied with |
| ISO 10993-7 (Biological evaluation - EO residuals) | Requirements for Ethylene oxide sterilization residuals | Complied with |
| ISO 10993-12 (Biological evaluation - Sample prep) | Sample preparation and reference materials | Complied with |
| ISO 11135 (EO Sterilization) | Requirements for sterilization process | Complied with |
| ISO 11607-2 (Packaging for sterilized devices) | Validation requirements for packaging | Complied with |
| SAL (Sterility Assurance Level) | 10-6 | Met (Reported in Device Description) |
| Endotoxin Limit | 20 EU per device | Met (Reported in Device Description) |
| Sterile Hypodermic needle for Single use | ||
| ISO 9626 (Stainless steel needle tubing) | Requirements and test methods for needle tubing | Complied with |
| ISO 7864 (Sterile hypodermic needles for single use) | Requirements and test methods | Complied with |
| ISO 10993-4 (Biological evaluation - Blood interaction) | Selection of Tests for Interactions with Blood | Complied with, Hemocompatibility carried out |
| ISO 10993-5 (Biological evaluation - Cytotoxicity) | Tests for In Vitro Cytotoxicity | Complied with, Cytotoxicity carried out |
| ISO 10993-10 (Biological evaluation - Irritation/Sensitization) | Tests for Irritation and Skin Sensitization | Complied with, Irritation and Sensitization carried out |
| ISO 10993-11 (Biological evaluation - Systemic Toxicity) | Tests for Systemic Toxicity | Complied with, Acute Systemic Toxicity carried out |
| USP 788 (Particulate Matter in Injections) | Requirements for particulate matter | Complied with |
| ISO 10993-7 (Biological evaluation - EO residuals) | Requirements for Ethylene oxide sterilization residuals | Complied with |
| ISO 10993-12 (Biological evaluation - Sample prep) | Sample preparation and reference materials | Complied with |
| ISO 11135 (EO Sterilization) | Requirements for sterilization process | Complied with |
| ISO 11607-2 (Packaging for sterilized devices) | Validation requirements for packaging | Complied with |
| SAL (Sterility Assurance Level) | 10-6 | Met (Reported in Device Description) |
| Endotoxin Limit | 20 EU per device | Met (Reported in Device Description) |
Regarding an AI-enabled device and its study, the following information is NOT available in the provided document:
- 1. Table of acceptance criteria and reported device performance for an AI model: Not applicable, as this is not an AI device.
- 2. Sample size used for the test set and data provenance: No test set for an AI model is mentioned. The performance testing refers to physical tests on the medical devices themselves.
- 3. Number of experts used to establish ground truth & qualifications: Not applicable for an AI model's ground truth. The ground truth for the physical devices' performance is established by the specifications and test methods within the referenced ISO standards.
- 4. Adjudication method for the test set: Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: "No prospective clinical trials were conducted in support of this 510(K)."
- 6. If a standalone (algorithm only) performance was done: Not applicable, as there is no algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the physical devices, the "ground truth" is adherence to established engineering and material standards for safety and performance (e.g., fluid aspiration/injection, material biocompatibility, sterility).
- 8. The sample size for the training set: Not applicable, as there is no AI model.
- 9. How the ground truth for the training set was established: Not applicable, as there is no AI model.
In summary, the provided document details a 510(k) submission for conventional medical devices (syringes and needles) and their compliance with relevant international standards, not an AI-enabled medical device. Therefore, the specific criteria requested for AI devices are not found within this text.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 17, 2022
Shandong Zhushi Pharmaceutical Group Co., Ltd % Bruce Cai Technical Manager Humiss Inc. 5#501, No. 445, Renmin Road, Qingcun Town, Fengxian District Shanghai, 201414 China
Re: K212033
Trade/Device Name: Disposable Sterile Syringe, with/without needle; luer/luer-lock: Sterile Insulin Syringe for Single use, with needle: Sterile Hypodermic needle for Single use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI Dated: July 5, 2022 Received: July 11, 2022
Dear Bruce Cai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
{1}------------------------------------------------
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CAPT Alan M. Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K212033
Device Name
Disposable Sterile Syringe, with/without needle; luer/luer-lock
Indications for Use (Describe)
The Sterile Hypodermic Syringe for Single Use with/without need for medical purposes to inject fluid into or withdraw fluid from body.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Sterile Insulin Syringe for Single use, with needle
Indications for Use (Describe)
The sterile insulin syringe for single use with needle, with the callbration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.
The sterile insulin syringe for single use with needle, with the callbration unit of insulin for U-40 is a device intended for medical purposes for the manual aspiration of insulin and for the injection of insulin into parts of the body below the surface skin.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Sterile Hypodermic needle for Single use
Indications for Use (Describe)
The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{5}------------------------------------------------
K212033 510(k) SUMMARY
I. PREPARATION DATE: August 8, 2022
II. SUBMITTER
Manufacturer name: Shandong Zhushi Pharmaceutical Group Co., Ltd. Address; No. 6, Shande Road, Shan County, Heze City, Shandong Province, 274300, China Contact Person: Junhui Zhu Title: Manager Tel: +86-15764021131 Fax: +86-530-4265777 E-mail: 2307426957@gq.com
III. Correspondent Contact Information
Bruce Cai (Contact Person) Humiss Inc. Tel: +86-13585598660 E-mail: cc401vip@126.com Summary Preparation Date: 2021.4.21
IV. DEVICE
| Name of Device: | - Disposable Sterile Syringe, with/without needle; luer/luer-lock- Sterile Insulin Syringe for Single use, with needle- Sterile Hypodermic needle for Single use |
|---|---|
| Common Name | - Disposable Sterile Syringe- Disposable insulin syringe- Disposable Hypodermic needle |
| Classification Name | - Piston Syringe- Piston Syringe- Hypodermic Single Lumen Needle |
| Regulation Number | - 21 CFR 880.5860- 21 CFR 880.5860- 21 CFR 880.5570 |
| Product Code | - FMF- FMF- FMI |
| Device Class | - Class II |
V. PREDICATE DEVICE
K190002- Sterile Hypodermic Syringe for Single use with/without needle,
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Sterile Insulin Syringe for Single use with needle, Sterile Hypodermic needle for Single use.
VI. Device Description
| Models | Subject Device |
|---|---|
| Product name | Disposable Sterile Syringe, with/without needle; luer/luer-lock |
| Indications for use | The Sterile Hypodermic Syringe for Single Use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. |
| Configuration | Piston, Plunger, Barrel |
| Sterility condition | EO Sterilized |
| Environment of use | Prescription use |
| Intended users | Medical professionals and trained care givers |
| Single use | Yes |
| Operation mode | The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient. |
| Length | 83-152mm |
| Diameter | 50-31mm |
| Tip type | luer/luer-lock |
| Needle tip configuration | The blade angle of the injection needle is the long bevel angle. |
| Nozzle type | Luer / Lock, %6 conical, 1,2 mm |
| Barrel marking specs | 0.01ml-0.5ml |
| Graduation legibility | Legible |
| Needle cover dimensions | |
| Needle cover color | Transparent |
| Lubricant composition | Dimethicone |
| Barrel transparency | Transparent/ UV resistant |
| Needle cover strength | 15N (min. 2N max. 15N) |
| Hub/needle bond strength | min. 22-69 N |
| Product performance | Complied with ISO 7886-1, ISO 7864, ISO 9626 |
| Volume | 1mL, 2mL, 2.5mL, 3mL, 5mL, 10mL, 20mL, 25mL, 30mL, 50mL |
| Sizes | 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G |
| Needle Lengths | 13-38 mm |
| Piston material | Isoprene Rubber |
| Barrel material | PP |
| Plunger material | PP |
Table 5.1. Device Description Summary for Disposable Sterile Syringe
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| Needle material | PP, SUS304 |
|---|---|
| SAL | 10-6 |
| Endotoxin Limit | 20 EU per device |
| Biocompatibility | Complied with ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization Acute Systemic Toxicity, Hemolytical effect) |
| Models | Subject Device |
|---|---|
| Product name | Sterile Insulin Syringe for Single use, with needle |
| Indications for use | The sterile insulin syringe for single use with needle, withthe calibration unit of insulin for U-100, is a device intendedfor medical purposes for the manual aspiration of insulin,and for the injection of insulin into parts of the body belowthe surface skin.The sterile insulin syringe for single use with needle, withthe calibration unit of insulin for U-40 is a device intendedfor medical purposes for the manual aspiration of insulin,and for the injection of insulin into parts of the body belowthe surface skin. |
| Configuration | Needle Cap, Needle, Piston, Plunger, Barrel, End Cap |
| Sterility condition | EO Sterilized |
| Environment of use | Prescription use |
| Single use | Yes |
| Operation mode | The plunger of syringe can be pulled and pushed alonginside the barrel, allowing the syringe to take in and expelthe fluids through the connector to the patient. |
| Product performance | Complied with ISO 8537 |
| Volume | 0.5ml, 1ml volumes with fixed needle |
| Needle Lengths | 8mm |
| Piston material | Isoprene Rubber |
| Barrel material | PP |
| Plunger material | PP |
| Needle material | SUS304 |
| Needle Cap material | PE |
| End Cap material | PE |
| SAL | 10-6 |
| Endotoxin Limit | 20 EU per device |
| Biocompatibility | ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, SensitizationAcute Systemic Toxicity, Subchronic Toxicity, Hemolyticaleffect |
Table 5.2. Device Description Summary for Insulin Syringe
Table 5.3. Device Description Summary for Needle
| Models | Subject device |
|---|---|
| -------- | ---------------- |
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| Product name | Sterile Hypodermic needle for Single use |
|---|---|
| Indications for use | The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. |
| Configuration | Protective cap, Needle, Adhesives, Needle hub |
| Sterility condition | EO Sterilized |
| Environment of use | Prescription use |
| Intended users | Medical professionals and trained care givers |
| Configuration | Protective cap, Needle, Adhesives, Needle hub |
| Single use | Yes |
| Operation mode | For Manual Use Only, For Single Use only |
| Product performance | Complied with: ISO 7864, ISO 9626 |
| Sizes | 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 30G |
| Needle Lengths | 13-38 mm |
| Protective cap materials | PP |
| Adhesive | Epoxy resin |
| Needle Hub materials | PP |
| Needle material | SUS304 |
| SAL | 10-6 |
| Endotoxin Limit | 20 EU per device |
| Biocompatibility | Complied with ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization Acute Systemic Toxicity, Hemolytical effect) |
VII. Predicate Comparison
| Table 6.1 Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock |
|---|
| Predicate Comparison |
| Models | Subject Device | Predicate DeviceK190002 | Comparison |
|---|---|---|---|
| Product name | Disposable Sterile Syringe,with/without needle;luer/luer-lock | Sterile HypodermicSyringe for Single use,with/without needle | Similar |
| Product code | FMF | FMF | Same |
| Regulationnumber | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | II | II | Same |
| Indications foruse | The Sterile HypodermicSyringe for Single Usewith/without needle isintended to be used formedical purposes to injectfluid into or withdraw fluid | The Sterile HypodermicSyringe for Single Usewith/without needle isintended to be used formedical purposes to injectfluid into or withdraw | Same |
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| from body. | fluid from body. | ||
|---|---|---|---|
| Configuration | Piston, Plunger, Barrel | Piston, Plunger, Barrel | Same |
| Sterility condition | EO Sterilized | EO Sterilized | Same |
| Environment of use | Prescription use | Prescription use | Same |
| Intended users | Medical professionals and trained care givers | Medical professionals and trained care givers | Same |
| Single use | Yes | Yes | Same |
| Operation mode | The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient. | The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient. | Same |
| Label/labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Product performance | Complied with ISO 7886-1, ISO 7864, ISO 9626 | Complied with ISO 7886-1, ISO 7864, ISO 9626 | Same |
| Volume | 1mL, 2mL, 2.5mL, 3mL, 5mL, 10mL, 20mL, 25mL, 30mL, 50mL | 1mL, 3mL, 5mL, 6mL, 10mL, 20mL, 30mL, 35mL, 50mL and 60 mL | Difference 1 |
| Sizes | 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G | 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G | Difference 2 |
| Needle Lengths | 13-38 mm | 4-38 mm | Difference 3 |
| Patient contact component and material | |||
| Piston | Isoprene Rubber | Isoprene Rubber | Same |
| Barrel | PP | PP | Same |
| Plunger | PP | PP | Same |
| Needle | PP, SUS304 | PP, SUS304 | Same |
| Sterilization | |||
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
Table 6.2. Sterile Insulin Syringe for Single use, with needle Predicate Comparison
| Models | Subject Device | Predicate DeviceK190002 | |
|---|---|---|---|
| Product name | Sterile Insulin Syringe forSingle use, with needle | Disposable insulinsyringe | Same |
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| Product code | FMF | FMF | Same |
|---|---|---|---|
| Regulationnumber | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | II | II | Same |
| Indications foruse | The sterile insulin syringefor single use with needle,with the calibration unit ofinsulin for U-100, is a deviceintended for medicalpurposes for the manualaspiration of insulin, and forthe injection of insulin intoparts of the body below thesurface skin.The sterile insulin syringefor single use with needle,with the calibration unit ofinsulin for U-40 is a deviceintended for medicalpurposes for the manualaspiration of insulin, and forthe injection of insulin intoparts of the body below thesurface skin. | The sterile insulinsyringe for single usewith needle, with thecalibration unit ofinsulin for U-100, is adevice intended formedical purposes for themanual aspiration ofinsulin, and for theinjection of insulin intoparts of the body belowthe surface skin.The sterile insulinsyringe for single usewith needle, with thecalibration unit ofinsulin for U-40 is adevice intended formedical purposes for themanual aspiration ofinsulin, and for theinjection of insulin intoparts of the body belowthe surface skin. | Same |
| Configuration | Needle Cap, Needle, Piston,Plunger, Barrel, End Cap | Needle Cap, Needle,Piston, Plunger, Barrel,End Cap | Same |
| Sterilitycondition | EO Sterilized | EO Sterilized | Same |
| Environment ofuse | Prescription use | Prescription use | Same |
| Intended users | Patient use | Patient use | Same |
| Single use | Yes | Yes | Same |
| Operation mode | The plunger of syringe canbe pulled and pushed alonginside the barrel, allowingthe syringe to take in andexpel the fluids through theconnector to the patient. | The plunger of syringecan be pulled andpushed along inside thebarrel, allowing thesyringe to take in andexpel the fluids throughthe connector to the | Same |
| Label/labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Product performance | Complied with ISO 8537 | Complied with ISO 8537 | Same |
| Volume | 0.5ml, 1ml volumes with fixed needle | 0.3ml, 0.5ml, 1ml volumes with fixed needle | Difference 4 |
| Needle Lengths | 8mm | 8mm, 13mm | Difference 5 |
| Patient contact component and material | |||
| Piston | Isoprene Rubber | Isoprene Rubber | Same |
| Barrel | PP | PP | Same |
| Plunger | PP | PP | Same |
| Needle | PP, SUS304 | PP, SUS304 | Same |
| Needle cap / End Cap | PE/PE | PP/PP | Difference 6 |
| Sterilization | |||
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
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Table 6.3. Sterile Hypodermic needle for Single use Predicate Comparison
| Models | Subject Device | Predicate Device K190002 | |
|---|---|---|---|
| Product name | Sterile Hypodermic needle for Single use | Sterile Hypodermic needle for Single use | |
| Product code | FMI | FMI | |
| Regulation number | 21 CFR 880.5570 | 21 CFR 880.5570 | |
| Class | II | II | |
| Intended users | The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. | The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. | |
| Configuration | Protective cap, Needle, Adhesives, Needle hub | Protective cap, Needle, Adhesives, Needle hub | |
| Sterility condition | EO Sterilized | EO Sterilized | |
| Environment of use | Prescription use | Prescription use | |
| Single use | Yes | Yes |
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| Operation mode | For Manual Use Only, ForSingle Use only | For Manual Use Only,For Single Use only | |
|---|---|---|---|
| Productperformance | Complied with: ISO 7864,ISO 9626 | Complied with: ISO7864, ISO 9626 | |
| Sizes | 18G, 19G, 20G, 21G, 22G,23G, 24G, 25G, 26G, 27G,28G, 30G | 18G, 19G, 20G, 21G,22G, 23G, 24G, 25G,26G, 27G, 28G, 29G,30G | Difference 7 |
| Needle Lengths | 13-38 mm | 4-38 mm | Difference 8 |
| Protective capmaterials | PP | PP | |
| Adhesive | Epoxy resin | Epoxy resin | |
| Needle Hub | PP | PP | |
| Needle material | SUS304 | SUS304 | |
| SAL | 10-6 | 10-6 | |
| Endotoxin Limit | 20 EU per device | 20 EU per device |
VIII. Substantial Equivalence Discussion
7.1 Disposable Sterile Syringe Discussion
The indications for use statement for the Disposable Sterile Syringe subject device are identical to the predicate device. There are no technological differences between the predicate and subject devices except for the following: syringe volumes, needle gauge sizes, needle lengths.
- Difference 1: The subject device includes different syringe volumes compared to the predicate. The subject device includes 2mL, 2.5mL, volume syringes while the predicate does not include these sizes. The predicate device includes 6ml, 35ml and 60 ml syringe volumes which the subject device does not include. These slight differences have no adverse effect on clinical safety and performance. All the subject device hypodermic syringes are tested in accordance with ISO 7886-1 standard. The requirements of the standards are met.
- Difference 2: The subject device does not include needle gauges 28G, 29G, 30G while the predicate device includes these sizes. The needles are tested in accordance with ISO 7864 and ISO 9626 and released in accordance with the standards compliance. This was verified by performance testing according to ISO 7864 and ISO 9626.
- Difference 3: The predicate device includes additional needle lengths compared to the subject device. The subject device includes the following additional needle lengths: 13-38 mm. The needles are tested in accordance to ISO 7864 and ISO 9626 and released in accordance with the standards compliance. This was verified by performance testing according to ISO 7864 and ISO 9626.
7.2 Insulin Syringe Discussion
The indications for use statement for the Sterile Insulin Syringe are identical to the predicate
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device. There are no technological differences between the subject and the predicate device except for the following: syringe volumes, needle lengths and Needle cap/End Cap material. This was verified by performance testing according to ISO 8537. The intended use, principle of operation, materials, specifications, and sterilization information for the subject device are the same as for the predicate device. Therefore, it can be determined that the proposed device is substantially equivalent to the predicate device.
- Difference 4: The subject device includes different syringe volumes compared to the predicate. The subject device does not include 0.3ml volume syringes while the predicate includes this size. These slight differences have no adverse effect on clinical safety and performance. The subject device insulin syringe is tested in accordance with ISO 8537 standard. The requirements of the standards are met.
- Difference 5: The subject device includes different syringe volumes compared to the predicate. The subject device does not include 13mm needle while the predicate includes this length. These slight differences have no adverse effect on clinical safety and performance. The subject device insulin syringe is tested in accordance with ISO 8537 standard. The requirements of the standards are met.
- Difference 6: The Needle cap and End Cap of the subject device is PE, while the predicate device material is PP. Biocompatibility studies are carried out in according to ISO 10993-1. Biological safety was demonstrated. The intended use, principle of operation, and sterilization information for the subject device are the same as the predicate device. The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. Therefore, it can be determined that the proposed device is substantially equivalent to the predicate device.
7.3 Needle Discussion
The indications for use statement for the subject device is identical to the predicate device. There are no technological differences between the subject and the predicate device except for the following: needle gauge sizes and needle length.
- Difference 7: The subject device includes additional needle gauges compared to the predicate. The subject device does not include needle gauges 29G while the predicate device includes these sizes. The needles are tested in accordance with ISO 7864 and ISO 9626 and released in accordance with the standards compliance. This was verified by performance testing according to ISO 7864 and ISO 9626.
- Difference 8: The predicate device includes additional needle lengths compared to the subject device. The subject device includes the following additional needle lengths: 13-38 mm. The needles are tested in accordance to ISO 7864 and ISO 9626 and released in accordance with the standards compliance. This was verified by performance testing according to ISO 7864 and ISO 9626.
VIV. Performance Testing
8.1 Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock
The Sterile Hypodermic Syringe for Single use described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
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- . ISO 9626 Second edition: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- ISO 7886-1 Second edition 2017-05 Sterile hypodermic syringes for single use Part 1: . Syringes for manual use
- . ISO 7864:2016 Fourth Edition: Sterile hypodermic needles for single use - Requirements and test methods
- . ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- . ISO 10993-4:2017 Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood
- . ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
- . ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
- . ISO 10993-11:2017 Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity
- USP 788 Particulate Matter in Injections
- . ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- . ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
- . ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
- . ISO 11607-2:2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
The Sterile Hypodermic Syringe for Single use is considered in the category of "External Communicating Devices" and are accepted to be in contact for a period less than 24 hours with "indirect blood path". Thus, cytotoxicity (ISO 10993-5:2009, irritation and sensitization (ISO 10993-10:2010), acute systemic toxicity (ISO 10993-11:2017), hemocompatibility (EN ISO 10993-4:2017) were carried out for the device in question.
8.2 Sterile Insulin Syringe for Single use, with needle
The Sterile Insulin Syringe for Single use described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
- ISO 8537 Third edition 2016-03-15 Sterile single-use syringes, with or without needle, for insulin
- . ISO 10993-4:2017 Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood
- ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests for In Vitro . Cytotoxicity
- . ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
- . ISO 10993-11:2017 Biological Evaluation of Medical Devices - Part 11: Tests for
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Systemic Toxicity
- USP 788 Particulate Matter in Injections
- . ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- . ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
- . ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO 11607-2:2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
The Sterile Insulin Syringe for Single use is considered in the category of "External Communicating Devices" and are accepted to be in contact for a period between 24 hours - 30 days because of repetitive use of patient with "indirect blood path". Thus, cytotoxicity (ISO 10993-5:2009, irritation and sensitization (ISO 10993-10:2010), acute systemic toxicity (ISO 10993-11:2017), sub-acute systemic toxicity (ISO 10993-11:2017), sub-chronic systemic toxicity (ISO 10993-11:2017), hemocompatibility (EN ISO 10993-4:2017) were carried out for the device in question.
8.3 Sterile Hypodermic needle
The Sterile Hypodermic needle described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
- ISO 9626 Second edition: Stainless steel needle tubing for the manufacture of medical • devices - Requirements and test methods
- . ISO 7864:2016 Fourth Edition: Sterile hypodermic needles for single use - Requirements and test methods
- . ISO 10993-4:2017 Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood
- . ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
- . ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
- . ISO 10993-11:2017 Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity
- . USP 788 Particulate Matter in Injections
- . ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- . ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
- . ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
- . ISO 11607-2:2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
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The Sterile Hypodermic needle is considered in the category of "External Communicating Devices" and are accepted to be in contact for a period less than 24 hours with "indirect blood path". Thus, cytotoxicity (ISO 10993-5:2009, irritation and sensitization (ISO 10993-10:2010), acute systemic toxicity (ISO 10993- 11:2017), hemocompatibility (EN ISO 10993-4:2017) were carried out for the device in question.
X. Clinical study
No prospective clinical trials were conducted in support of this 510(K).
XI. Conclusion
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The subject devices are substantially equivalent to the predicate devices with respect to the indications for use, target populations, treatment method, and technological characteristics.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).