(421 days)
The Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.
The proposed devices, Pen Needles, are a single-use device, which is designed for use with a pen injector for the subcutaneous injection of insulin. The proposed devices include two models, i.e. Easydrip Pen Needle and Easydrip Plus Pen Needle. Both models have the same construction, operation methods and similar materials. Both models consist of needle tubing, needle tip shield, needle base, needle container, sealing dialysis paper, glue and silicone oil. The needle base of the device can be screwed onto compatible insulin pens. The only minor differences between the Easydrip and Easydrip Plus models are the outer shape and the material of the Needle tip shield. The Easydrip Needle tip shield is slightly shorter in length and more tapered than the Easydrip Plus Needle tip shield. The material of construction of the Easydrip Needle tip shield is polyethylene, while the Easydrip Plus Needle tip shield is polypropylene.
The Pen Needles are offered in various gauge sizes and needle lengths. The proposed devices are irradiation sterilized to achieve a Sterility Assurance Level (SAL) of 10-9.
The provided text is a 510(k) Summary for a medical device (Easydrip Pen Needle, Easydrip Plus Pen Needle). It describes the device's features, intended use, and comparative testing against a predicate device to demonstrate substantial equivalence.
However, the information requested in your prompt (acceptance criteria, study details, sample sizes, expert involvement, ground truth, MRMC study, etc.) is primarily relevant to studies validating the performance of Artificial Intelligence (AI) or machine learning (ML) models in medical diagnosis or image analysis.
The document provided, K193422, is for a physical medical device (a pen needle), not an AI/ML powered device. Therefore, the concepts of "acceptance criteria for an AI model," "training set," "test set ground truth established by experts," "MRMC study," or "standalone algorithm performance" are not applicable to this type of device submission.
The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical bench testing and biocompatibility testing to demonstrate the physical and biological safety and performance of the pen needle against established medical device standards (e.g., ISO standards).
Here's how I can address your prompt based on the provided document, interpreting "acceptance criteria" and "study" in the context of a physical medical device:
Acceptance Criteria and Study for the Easydrip Pen Needle / Easydrip Plus Pen Needle
The acceptance criteria for the Easydrip Pen Needle and Easydrip Plus Pen Needle are primarily based on their conformance to international standards for hypodermic needles and insulin pen needles, along with demonstrating physical performance and biocompatibility comparable to a legally marketed predicate device.
1. A table of acceptance criteria and the reported device performance:
Since this document describes bench testing against technical standards and a predicate device, the "acceptance criteria" are the requirements set forth in those standards and the "reported device performance" is the statement of "Passed."
| Test (Acceptance Criteria Based On) | Reported Device Performance (Result) |
|---|---|
| Physical/Functional Performance: | |
| Materials (ISO 9626 specified tubing materials) | Passed |
| Dimensions (Fit test apparatus as per ISO 11608-2 item 7.2) | Passed |
| Flow rate through the needle (Annex A to ISO 11608-2) | Passed |
| Binding force between needle base and needle tubing (ISO 11608-2 Clause 9) | Passed |
| Needle tip appearance (ISO 11608-2 4.5) | Passed |
| Needle tubing flawlessness (ISO 7864:1993, 11.3) | Passed |
| Size of inside and outside diameter and puncturing force | Passed (Implicitly, covered by other tests) |
| Dislocation of measuring point patient end (ISO 11688-2 Table 2, Clause 8) | Passed |
| Functional compatibility with needle-based injected systems (ISO 11608-2 Clause 11) | Passed |
| Ease of assemble and disassembly (ISO 11608-2 Clause 11 requirements) | Passed |
| Biocompatibility: | |
| Cytotoxicity (ISO 10093-5) | Passed / No cytotoxicity |
| Sensitization (ISO 10993-10) | Passed / No evidence of sensitization |
| Irritation (ISO 10993-10) | Passed / No evidence of skin irritation |
| Hemocompatibility (ISO 10993-4, ASTM F765) | Passed / No evidence of hemolysis |
| System toxicity (acute) (ISO 10993-11) | Passed / No systemic toxicity |
| Pyrogen (USP 40.NF 35 <151> Pyrogen Test) | Passed / No pyrogen |
| Particulate Matter (USP <788> Method 1) | Passed |
| Sterilization: | |
| Sterility Assurance Level (SAL) (Radiation sterilization, ISO 11737-2:2012) | Achieved an SAL of 10-6 |
2. Sample sizes used for the test set and the data provenance:
- Sample Size: The document does not explicitly state specific sample sizes for each test. For physical device testing against ISO standards, sample sizes are typically determined by the standard itself (e.g., lot sampling plans) or by statistical justification to achieve confidence in meeting the specifications.
- Data Provenance: The tests were performed as part of the submission by Sandstone Medical (Suzhou) Inc., located in China. These are non-clinical bench tests, not human data. The document implies these are prospective tests conducted specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not applicable as this is a physical medical device, not an AI/ML-powered device requiring expert adjudication for "ground truth." The "ground truth" for these tests are the objective measurements and technical requirements specified by the international standards (e.g., ISO 7864, ISO 9626, ISO 11608-2, ISO 10993 series, USP standards).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The tests are deterministic based on physical measurements and chemical/biological analyses against specified criteria, not subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant to AI/ML devices where reader performance (e.g., radiologists interpreting images) is assessed with and without AI assistance. This document is for a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an algorithm or AI device.
7. The type of ground truth used:
The "ground truth" for this device's performance is defined by:
- Compliance with established international technical standards (e.g., ISO 7864, ISO 9626, ISO 11608-2, ISO 10993 series).
- Objective physical and chemical measurements (e.g., flow rate, binding force, dimensions, cytotoxicity, pyrogenicity).
- Predicate device comparison: demonstrating that the proposed device performs "as safe and effective as" the predicate device, implying that the predicate's established safety and effectiveness serve as a benchmark.
8. The sample size for the training set:
Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/ML device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
February 2, 2021
Sandstone Medical (Suzhou) Inc. % Elly Xu Consultant Manager Shenzhen Joyantech Consulting Co., Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, 518000 Cn
Re: K193422
Trade/Device Name: Easydrip Pen Needle, Easydrip Plus Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: November 27, 2020 Received: December 28, 2020
Dear Elly Xu:
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
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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,
For Rumi Young Acting 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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Indications for Use
510(k) Number (if known) K193422
Device Name
Easydrip Pen Needle, Easydrip Plus Pen Needle
Indications for Use (Describe)
The Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
510(k) Number: K193422
1. Contact Details
- 1.1 Applicant information
| Applicant Name | Sandstone Medical (Suzhou) Inc. | ||
|---|---|---|---|
| Address | No.168 Pu TuoShan Road, New District, Suzhou 215153, China | ||
| Phone No. | 86-0512-65799368 | ||
| Fax No. | 86-0512-65799368 | ||
| Contact person | Juanjuan Sun | ||
| Contact person's e-mail | juanjuans@sandstonemed.com | ||
| Company e-mail | juanjuans@sandstonemed.com | ||
| Date Prepared | November 29, 2019 | ||
| Website | www.sandstone.com |
1.2 Consultant information
| Name | Shenzhen Joyantech Consulting Co., Ltd |
|---|---|
| 皇 in 大 | |
| Address | 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian Avenue, |
| Xili Town, Nanshan District, Shenzhen, Guangdong Province, China. | |
| Phone No. | +86-755-86069197 |
| Contact person | Joyce Yang, Field Fu |
| Contact person's e-mail | joyce@cefda.com; field@cefda.com |
| Website | http://www.cefda.com |
2. Device information
| Trade name | Easydrip Pen Needle, Easydrip Plus Pen Needle |
|---|---|
| Common name | Insulin Pen Needle |
| Model | 29G/30G/31G/32G/33G |
| Classification | II |
| Classification name | Needle, Hypodermic, Single Lumen |
| Product code | FMI |
| Regulation No. | 21 CFR 880.5570 |
Legally Marketed Predicate Device 3.
| Trade Name | Verifine® Common Type Insulin Pen Needle |
|---|---|
| 510(k) Number | K161950 |
| Product Code | FMI |
| Manufacturer | Promisemed Hangzhou Meditech Co., Ltd. |
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4. Device Description
The proposed devices, Pen Needles, are a single-use device, which is designed for use with a pen injector for the subcutaneous injection of insulin. The proposed devices include two models, i.e. Easydrip Pen Needle and Easydrip Plus Pen Needle. Both models have the same construction, operation methods and similar materials. Both models consist of needle tubing, needle tip shield, needle base, needle container, sealing dialysis paper, glue and silicone oil. The needle base of the device can be screwed onto compatible insulin pens. The only minor differences between the Easydrip and Easydrip Plus models are the outer shape and the material of the Needle tip shield. The Easydrip Needle tip shield is slightly shorter in length and more tapered than the Easydrip Plus Needle tip shield. The material of construction of the Easydrip Needle tip shield is polyethylene, while the Easydrip Plus Needle tip shield is polypropylene.
The Pen Needles are offered in various gauge sizes and needle lengths. The proposed devices are irradiation sterilized to achieve a Sterility Assurance Level (SAL) of 10-9.
| Type | Gauge(G) | Needle OD.(mm) | Needle available length(mm) |
|---|---|---|---|
| Easydrip | 29 | 0.33 | 10 |
| 29 | 0.33 | 12 | |
| 29 | 0.33 | 12.7 | |
| 30 | 0.30 | 6 | |
| 30 | 0.30 | 8 | |
| 30 | 0.30 | 10 | |
| 31 | 0.25 | 5 | |
| 31 | 0.25 | 6 | |
| 31 | 0.25 | 8 | |
| 32 | 0.23 | 4 | |
| 32 | 0.23 | 5 | |
| 33 | 0.20 | 4 | |
| 33 | 0.20 | 5 | |
| Easydrip Plus | 29 | 0.33 | 10 |
| 29 | 0.33 | 12 | |
| 29 | 0.33 | 12.7 | |
| 30 | 0.30 | 6 | |
| 30 | 0.30 | 8 | |
| 30 | 0.30 | 10 | |
| 31 | 0.25 | 5 | |
| 31 | 0.25 | 6 | |
| 31 | 0.25 | 8 | |
| 32 | 0.23 | 4 | |
| 32 | 0.23 | 5 | |
| 33 | 0.20 | 4 | |
| 33 | 0.20 | 5 |
The dimension for both Easydrip Pen Needle and Easydrip Plus Pen Needle are shown as below.
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Intended Use/Indication for Use 5.
The Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.
6. Product compatibility
The Pen Needle may be used with Type A compatible insulin delivery system, including:
| Pen name | Pen Manufacturer |
|---|---|
| NovoPen 5 | Novo Nordisk |
| AUTOPEN 24 | Owen mumford |
| Gansulin Pen | Tonghua Dongbao |
| Ypsopen | Ypsomed AG |
| UNIPEN | United Laboratories |
| XiuLin Pen | Gan & Lee |
| HumaPen Ergoll | EILILILLY |
| Byetta | Baxter Pharmaceutical |
| Victoza Pen | Novo nordisk |
| Item | Proposed Device:Easydrip Pen Needle | Proposed Device:Easydrip Plus PenNeedle | Predicate Device:Common Type InsulinPen Needle(K161950) | Comments |
|---|---|---|---|---|
| Product Code | FMI | FMI | FMI | Same |
| Indications forUse | The Pen Needle isintended for use withpen injector device forsubcutaneousinjection of insulin. | The Pen Needle isintended for use withpen injector device forsubcutaneousinjection of insulin. | The Insulin PenNeedle is intended foruse with pen injectordevices for thesubcutaneousinjection of insulin. | Same |
| Configurationand Material | Needle tubing (NeedleTube):304 Stainlesssteel | Needle tubing (NeedleTube):304 Stainlesssteel | Needle tubing (NeedleTube):304 Stainlesssteel, | Same |
| Needle tip shield(Tube Sheath):Polyethylene | Needle tip shield(Tube Sheath):Polypropylene | Needle tip shield(Tube Sheath):Polypropylene | Difference#1 | |
| Needle base (Hub):Polypropylene | Needle base (Hub):Polypropylene | Needle hub:Polypropylene | Same | |
| Needle container (HubSheath): Polyethylene | Needle container (HubSheath): Polyethylene | Needle container (HubSheath): Polyethylene | Same | |
| Item | Proposed Device:Easydrip Pen Needle | Proposed Device:Easydrip Plus Pen Needle | Predicate Device:Common Type Insulin Pen Needle(K161950) | Comments |
| Sealing dialysis paper(Sealed Paper):Sealing dialysis paper | Sealing dialysis paper(Sealed Paper):Sealing dialysis paper | Sealing dialysis paper(Sealed Paper):Sealing dialysis paper | Sealing dialysis paper(Sealed Paper):Sealing dialysis paper | Same |
| Operation mode | Manual | Manual | Manual | Same |
| Needle Gauge | 29G/30G/31G/32G/33G | 29G/30G/31G/32G/33G | 29G/30G/31G/32G/33G | Same |
| Needle length | 4mm, 5mm, 6mm,8mm, 10mm,12mm,12.7mm | 4mm, 5mm, 6mm,8mm, 10mm,12mm,12.7mm | 4mm, 5mm, 6mm,8mm,12mm | Difference #2 |
| Design of theneedle base | Image: Easydrip Pen Needle base | Image: Easydrip Plus Pen Needle base | Image: Common Type Insulin Pen Needle base | Same |
| Sterilization | SAL: 10-6Method: IrradiationSterilized | SAL: 10-6Method: IrradiationSterilized | SAL: 10-6Method: EO Sterilized | Difference #3 |
| Performance | Complied with ISO7864, ISO 9626, andISO 11608-2 | Complied with ISO7864, ISO 9626, andISO 11608-2 | Complied with ISO7864, ISO 9626, andISO 11608-2 | Same |
| Shelf Life | 5 years | 5 years | 5 years | Same |
| Single Use | Yes | Yes | Yes | Same |
| Biocompatibility | Complied with ISO10993 seriesstandards | Complied with ISO10993 seriesstandards | Complied with ISO10993 seriesstandards | Same |
| Cytotoxicity | No cytotoxicity | No cytotoxicity | No cytotoxicity | Same |
| Skin Irritation | No evidence of skinirritation | No evidence of skinirritation | No evidence of skinirritation | Same |
| Skin Sensitization | No evidence ofsensitization | No evidence ofsensitization | No evidence ofsensitization | Same |
| Acute Systemic Toxicity | No systemic toxicity | No systemic toxicity | No systemic toxicity | Same |
| Hemolysis | No evidence ofhemolysis | No evidence ofhemolysis | No evidence ofhemolysis | Same |
| Pyrogen | No pyrogen | No pyrogen | No pyrogen | Same |
7. Substantial Equivalence Comparison
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8. Substantial Equivalence Discussion
Difference #1 - Needle tip shield material
The needle tip shield of the Easydrip Pen Needle is different from that of the predicate. However, the difference in material is addressed through biocompatibility testing according to ISO 10993 series standards. The biocompatibility testing demonstrates that the difference in material does not affect the safety and effectiveness of the device.
Difference #2 - Needle length
Compared to the predicate device, the proposed device has an additional 12.7mm needle length. The bench tests of the needle with 12.7mm needle length demonstrated conformance to ISO 7864, ISO 9626, and ISO 11608-2. Therefore, the additional needle length does not affect the safety and effectiveness of the device.
Difference #3 - Sterilization method
The subject device is irradiation sterilized while the predicate device is Ethylene Oxide sterilized. While the sterilization methods between the proposed device and the predicate device are different, validation testing was performed to validate the sterilization method. The sterilization report showed that the sterilization effect of the proposed device can achieve a Sterility Assurance Level (SAL) of 10°, and the radiation dose audit test reports showed that the minimum gamma radiation dose to achieve a 10° SAL was acceptable according to ISO 11737-2:2012. Therefore, the difference in sterilization does not affect the safety and effectiveness of the device.
Non-clinical Testing 9.
All non-clinical testing performed on the subject devices is to demonstrate substantial equivalence to the predicate device. Tests setup and execution are performed in accordance with applicable standards.
| Test | Requirements | Results | |
|---|---|---|---|
| Materials | The needle shall be made of tubing materialsspecified in ISO 9626. | Passed | |
| Dimensions | The needles shall fit the test apparatusspecified in item 7.2 of ISO 11608-2. | Passed | |
| Flow rate through the needle | The needles were tested in accordance withAnnex A to ISO 11608-2. | Passed | |
| Binding force between needle base andneedle tubing | The union of the hub and needle tube shall notbreak when tested in accordance with Clause 9of ISO 11608-2. | Passed | |
| Test | Requirements | Results | |
| Needle tip appearance, needle tubingflawlessness, size of inside and outsidediameter and puncturing force | The needle tip appearance shall fulfil the 4.5 ofISO 11608-2.The needle tubing flawlessness shall fulfil therequirements of ISO 7864:1993, 11.3. | Passed | |
| Dislocation of measuring point patientend | Dislocation of the cannula point at the patientend shall be in accordance with Table 2 (ISO11688-2) when tested in accordance withClause 8 of ISO 11608-2. | Passed | |
| Functional compatibility withneedle-based injected systems | Compatibility with any NIS shall be claimedonly after testing in accordance with Clause 11of ISO 11608-2. | Passed | |
| Ease of assemble and disassembly | Attachment of the needle shall be possiblewithout removing the needle from its openedunit packaging. Compliance is checkedaccording to the requirements of Clause 11 ofISO 11608-2. | Passed | |
| Cytotoxicity | ISO 10093-5 Biological evaluation of medicaldevices -Part 5: Tests for in vitro cytotoxicity | Passed | |
| Sensitization | ISO 10993-10 Biological evaluation of medicaldevices -Part 10:Tests for irritation and skinsensitization | Passed | |
| Irritation | ISO 10993-10 Biological evaluation of medicaldevices -Part 10:Tests for irritation and skinsensitization | Passed | |
| Biocompatibility | Hemocompatibility | ISO 10993-4 Biological evaluation of medicaldevices Part 4: Selection of tests forinteractions with bloodASTM F765 Standard Practice for Assessmentof Hemolytic Properties of Materials | Passed |
| System toxicity(acute) | ISO 10993-11:2006/(R)2010, Biologicalevaluation of medical devices - Part 11: Testsfor systemic toxicity. | Passed | |
| Pyrogen | USP 40.NF 35 <151> Pyrogen Test. | Passed | |
| Particulate Matter | USP <788> Particulate Matter in Injections,Method 1: Light Obscuration Particle Count Test | Passed |
The following performance data was provided to support a substantial equivalence determination.
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10. Clinical Testing
No clinical test data was included in this submission.
11. Conclusions
Based on device comparison information and non-clinical bench testing, the Pen Needle and the predicate device have the same indication for use, similar materials of construction, and similar specifications. The bench tests and biocompatibility tests support that the proposed device is as safe and effective as the predicate device, and the differences between them do not raise any new
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questions of safety and effectiveness. Therefore, the proposed device is determined to be
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Substantially Equivalent to legally marketed predicate device.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).