(189 days)
The AUTO DISABLE SYRINGE is intended for use in the suction of vaccine for medical purposes. Additionally , after injection to the body, the plunger can be automatically locked by the triggered mechanism to prevent the re-use of this syringe.
The AUTO DISABLE SYRINGE is designed for the hypodermic injection of the intended micro scale solution. It has the automatic function in the structure of the syringe which after injection of an intended fixed dose locks the syringe to prevent re-use of the syringe. It can be widely used for injection of vaccine for the immunization.
The syringe consists of a calibrated hollow barrel, a movable plunger, a rubber stopper (piston) assembled at end of the plunger, and a steel clip installed between the barrel and the plunger that functions to prevent re-use of the syringe.
At the end of the barrel, a fixed an unmovable needle is installed, and a needle cap covers the needle. The zero line and nominal capacity line are printed outside of barrel. The main materials are PP, latex free (polyisoprene rubber) and stainless steel.
This document describes the regulatory approval for an "Auto Disable Syringe" (K210464). The acceptance criteria are essentially the compliance with various international standards, and the "study" that proves the device meets these criteria is a series of non-clinical, functional performance, sterility, shelf-life, and biocompatibility tests.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| Functional Performance (ISO 7864:2016) | In conformance with ISO 7864:2016 for: |
| - Fragmentation test | Passed |
| - Determination of flow rate | Passed |
| - Lubricant: Penetration force and drag force | Passed |
| - Bonding strength | Passed |
| Functional Performance (ISO 7886-3 & ISO 7886-1) | In conformance with ISO 7886-3 and ISO 7886-1 for: |
| - Limits for acidity and alkalinity | Passed |
| - Limits for extractable metals | Passed |
| - Lubricant: Penetration force and drag force | Passed |
| - Tolerance on nominal capacity | Passed |
| - Graduated scale | Passed |
| - Barrel- dimensions and flanges | Passed |
| - Plunger stopper and assembly - fitness of stopper /plunger in barrel | Passed |
| - Integrated needle | Passed |
| - Sharps protection features | Passed (Implicit by "Auto-disable syringe feature" and compliance with standards covering this) |
| - Dead space | Passed |
| - Freedom from air and liquid leakage | Passed |
| - Auto-disable syringe feature | Passed (device description states "the plunger can be automatically locked by the triggered mechanism to prevent the re-use of this syringe.") |
| Functional Performance (ISO9626) | In conformance with ISO9626 for: |
| - Limits for acidity and alkalinity | Passed |
| - Designated metric size | Passed |
| - Stiffness | Passed |
| - Resistance to breakage | Passed |
| - Resistance to corrosion | Passed |
| Sterility, Shipping and Shelf-Life (ISO11135:2014, ISO11607-1:2019, ISO11607:2019, ISO10993-7:2008, ASTM D4169-16, ASTM F88/F88-15, ASTM F1886-16, ASTM F1929-15, ASTM F1980-16) | Validated/Conducted: |
| - EO sterilization validation | Conducted in accordance with ISO11135:2014, result 10-6 sterility assurance level. |
| - Sterilant residuals | Evaluated per ISO10993-7:2008. Average daily dose to patient of EO < 4mg/device and ECH < 9mg/device. |
| - Package validation (integrity, environmental conditioning, transportation) | Conducted in accordance with ISO11607-1:2019, ISO11607:2019, and ASTM D4169-16. All packaging deemed acceptable for protection of product and sterility maintenance. |
| - Sterile Barrier Packaging Testing (Seal strength, Visual Inspection, Dye penetration) | Performed per ASTM F88/F88-15, ASTM F1886-16, ASTM F1929-15. Results not explicitly stated but implied as acceptable within package validation. |
| - Shelf life | 5 years validated using ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. |
| Biocompatibility (ISO 10993-1:2018) | Conducted per ISO 10993-1, device classified as Externally Communicating Device, Blood Path Indirect, Limited Contact (<24 hours): |
| - Cytotoxicity (ISO10993-5:2009) | Passed |
| - Sensitization (ISO10993-10:2014) | Passed |
| - Irritation (ISO10993-10:2017) | Passed |
| - Acute Systemic Toxicity (ISO10993-11:2017) | Passed |
| - Pyrogenicity (ISO10993-4:2017) | Passed |
| - Hemocompatibility (ISO10993-4:2017) | Passed |
| - Particulate matter (USP<788>) | Passed |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes for each test mentioned (e.g., how many syringes were tested for flow rate, or how many were used in biocompatibility studies). It broadly states that the "AUTO DISABLE SYRINGE described in this summary were tested".
Regarding data provenance:
- Country of Origin: The manufacturer is Anhui Tiankang Medical Technology Co., Ltd. from Tianchang, Anhui, China. It is highly probable that the non-clinical testing was performed in China or by labs commissioned by the Chinese manufacturer.
- Retrospective or Prospective: The testing described (functional performance, sterility, shelf-life, biocompatibility) is typically prospective and conducted specifically for regulatory submission to demonstrate compliance with standards and safety/effectiveness of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is a medical device (syringe), not an AI/diagnostic imaging device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of medical image interpretation (e.g., radiologists) does not apply. The "ground truth" for this device's performance is established by objective measurements against recognized international standards through laboratory testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this device's performance is determined by objective physical, chemical, and biological tests against established standards, not by human interpretation that would require adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical medical device (syringe), not a diagnostic imaging device utilizing AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (syringe), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is established by objective measurements and pass/fail criteria defined by recognized international standards (e.g., ISO, ASTM, USP). For example:
- Functional performance: Measurements of flow rate, penetration force, bonding strength, tolerance on nominal capacity, etc., against predefined limits in standards like ISO 7864, ISO 7886, ISO 9626.
- Sterility: Demonstrated sterile assurance level (SAL) of 10-6 per ISO 11135.
- Biocompatibility: Absence of cytotoxic, sensitizing, irritating, systemic toxic, pyrogenic, or hemocompatible effects as determined by tests outlined in ISO 10993 series.
- Shelf-life: Maintenance of package integrity and device functionality over a specified period (5 years) as per ASTM F1980.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a physical medical 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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 24, 2021
Anhui Tiankang Medical Technology Co.,Ltd. Bai Baodong General Manager No.228 Weiyi Road, Economic Development Zone Tianchang, Anhui 239300 China
Re: K210464
Trade/Device Name: Auto Disable Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: July 23, 2021 Received: July 26, 2021
Dear Bai Baodong:
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 CAPT. Alan M. Stevens Assistant Director Injection Devices Team 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) K210464
Device Name AUTO DISABLE SYRINGE
Indications for Use (Describe)
The AUTO DISABLE SYRINGE is intended for use in the suction of vaccine for medical purposes. Additionally , after injection to the body, the plunger can be automatically locked by the triggered mechanism to prevent the re-use of this syringe.
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) |
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K210464 510(K) Summary
Date prepared: August 24, 2021
Submitter Name and Address:
| Submitter Name: | Anhui Tiankang Medical Technology Co., Ltd. |
|---|---|
| Address: | No.228 Weiyi Road, Economic Development Zone, Tianchang City.Anhui, China |
| Contact Person: | Bai Baodong, General Manager |
| TEL: | +86-550-7309187 |
| FAX: | +86-550-7308901 |
| E-mail: | tkquality@126.com |
Submission Devices Information:
Trade/Proprietary Name: AUTO DISABLE SYRINGE Classification name: Syringe, piston Class: II. Product codes: FMF Regulation number: 21CFR880.5860,
Submission Type: 510(K)
Predicate Device Information:
Company Name: Becton, Dickinson, and Company Device name: BD SoloShot Mini Syringe/ BD Auto Disable Syringe 510(K) Number: K201234
Device Description
- Indication for use:
The AUTO DISABLE SYRINGE is intended for use in the suction and injection of vaccine for medical purposes. Additionally, after injection to the plunger can be automatically locked by the triggered mechanism to prevent the re-use of this syringe.
- Design of syringe:
The AUTO DISABLE SYRINGE is designed for the hypodermic injection of the intended micro
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scale solution. It has the automatic function in the structure of the syringe which after injection of an intended fixed dose locks the syringe to prevent re-use of the syringe. It can be widely used for injection of vaccine for the immunization.
- Structure of syringe (with needle):
The syringe consists of a calibrated hollow barrel, a movable plunger, a rubber stopper (piston) assembled at end of the plunger, and a steel clip installed between the barrel and the plunger that functions to prevent re-use of the syringe.
At the end of the barrel, a fixed an unmovable needle is installed, and a needle cap covers the needle. The zero line and nominal capacity line are printed outside of barrel. The main materials are PP, latex free (polyisoprene rubber) and stainless steel.
The AUTO DISABLE SYRNGE is for Prescription (Rx) use only
Product models:
| Description | Needle Length |
|---|---|
| 1cc(ml), with needle:23G | 3/8", 1/2", 3/4", 7/8", 1" |
| 1cc(ml), with needle:24G | 3/8", 1/2", 3/4", 7/8", 1" |
| 1cc(ml), with needle:25G | 3/8", 1/2", 3/4", 7/8", 1" |
| 1cc(ml), with needle:26G | 3/8" and 1/2" |
| 1cc(ml), with needle:27G | 3/8" and 1/2" |
| 1cc(ml), with needle:28G | 3/8" and 1/2" |
| 1cc(ml), with needle:29G | 3/8" and 1/2" |
| 1cc(ml), with needle:30G | 3/8" and 1/2" |
| Description | Needle Length |
|---|---|
| 0.5cc(ml), with needle:23G | 3/8", 1/2", 3/4", 7/8", 1" |
| 0.5cc(ml), with needle:24G | 3/8", 1/2", 3/4", 7/8", 1" |
| 0.5cc(ml), with needle:25G | 3/8", 1/2", 3/4", 7/8", 1" |
| 0.5cc(ml), with needle:26G | 3/8" and 1/2" |
| 0.5cc(ml), with needle:27G | 3/8" and 1/2" |
| 0.5cc(ml), with needle:28G | 3/8" and 1/2" |
| 0.5cc(ml), with needle:29G | 3/8" and 1/2" |
| 0.5cc(ml), with needle:30G | 3/8" and 1/2" |
| Description | Needle Length |
|---|---|
| 0.4cc(ml), with needle:23G | 3/8", 1/2", 3/4", 7/8", 1" |
| 0.4cc(ml), with needle:24G | 3/8", 1/2", 3/4", 7/8", 1" |
| 0.4cc(ml), with needle:25G | 3/8", 1/2", 3/4", 7/8", 1" |
| 0.4cc(ml), with needle:26G | 3/8" and 1/2" |
| 0.4cc(ml), with needle:27G | 3/8" and 1/2" |
| 0.4cc(ml), with needle:28G | 3/8" and 1/2" |
| 0.4cc(ml), with needle:29G | 3/8" and 1/2" |
| 0.4cc(ml), with needle:30G | 3/8" and 1/2" |
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| Description | Needle Length |
|---|---|
| 0.3cc(ml), with needle:23G | 3/8", 1/2", 3/4", 7/8", 1" |
| 0.3cc(ml), with needle:24G | 3/8", 1/2", 3/4", 7/8", 1" |
| 0.3cc(ml), with needle:25G | 3/8", 1/2", 3/4", 7/8", 1" |
| 0.3cc(ml), with needle:26G | 3/8" and 1/2" |
| 0.3cc(ml), with needle:27G | 3/8" and 1/2" |
| 0.3cc(ml), with needle:28G | 3/8" and 1/2" |
| 0.3cc(ml), with needle:29G | 3/8" and 1/2" |
| 0.3cc(ml), with needle:30G | 3/8" and 1/2" |
| Description | Needle Length |
|---|---|
| 0.25cc(ml), with needle:23G | 3/8", 1/2", 3/4", 7/8", 1" |
| 0.25cc(ml), with needle:24G | 3/8", 1/2", 3/4", 7/8", 1" |
| 0.25cc(ml), with needle:25G | 3/8", 1/2", 3/4", 7/8", 1" |
| 0.25cc(ml), with needle:26G | 3/8" and 1/2" |
| 0.25cc(ml), with needle:27G | 3/8" and 1/2" |
| 0.25cc(ml), with needle:28G | 3/8" and 1/2" |
| 0.25cc(ml), with needle:29G | 3/8" and 1/2" |
| 0.25cc(ml), with needle:30G | 3/8" and 1/2" |
| Description | Needle Length |
|---|---|
| 0.2cc(ml), with needle:23G | 3/8", 1/2", 3/4", 7/8", 1" |
| 0.2cc(ml), with needle:24G | 3/8", 1/2", 3/4", 7/8", 1" |
| 0.2cc(ml), with needle:25G | 3/8", 1/2", 3/4", 7/8", 1" |
| 0.2cc(ml), with needle:26G | 3/8" and 1/2" |
| 0.2cc(ml), with needle:27G | 3/8" and 1/2" |
| 0.2cc(ml), with needle:28G | 3/8" and 1/2" |
| 0.2cc(ml), with needle:29G | 3/8" and 1/2" |
| 0.2cc(ml), with needle:30G | 3/8" and 1/2" |
| Description | Needle Length |
|---|---|
| 0.1cc(ml), with needle:23G | 3/8", 1/2", 3/4", 7/8", 1" |
| 0.1cc(ml), with needle:24G | 3/8", 1/2", 3/4", 7/8", 1" |
| 0.1cc(ml), with needle:25G | 3/8", 1/2", 3/4", 7/8", 1" |
| 0.1cc(ml), with needle:26G | 3/8" and 1/2" |
| 0.1cc(ml), with needle:27G | 3/8" and 1/2" |
| 0.1cc(ml), with needle:28G | 3/8" and 1/2" |
| 0.1cc(ml), with needle:29G | 3/8" and 1/2" |
| 0.1cc(ml), with needle:30G | 3/8" and 1/2" |
| Description | Needle Length |
|---|---|
| 0.05cc(ml), with needle:23G | 3/8", 1/2", 3/4", 7/8", 1" |
| 0.05cc(ml), with needle:24G | 3/8", 1/2", 3/4", 7/8", 1" |
| 0.05cc(ml), with needle:25G | 3/8", 1/2", 3/4", 7/8", 1" |
| 0.05cc(ml), with needle:26G | 3/8" and 1/2" |
| 0.05cc(ml), with needle:27G | 3/8" and 1/2" |
| 0.05cc(ml), with needle:28G | 3/8" and 1/2" |
| 0.05cc(ml), with needle:29G | 3/8" and 1/2" |
| 0.05cc(ml), with needle:30G | 3/8" and 1/2" |
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Comparison of technological characteristics with the predicate:
| Elements ofcomparison | Subject device | Predicate device: | Comments |
|---|---|---|---|
| AUTO DISABLESYRINGE | BD SoloShot MiniSyringe/ BD Auto DisableSyringe (K201234) | ||
| Indications forUse | The AUTO DISABLESYRINGE is intendedfor use in the suctionand injection of vaccinefor medical purposes.Additionally, afterinjection to the body,the plunger can beautomatically locked bythe triggeredmechanism to preventthe re-use of thissyringe. | BD SoloShot MiniSyringe/ BD AutoDisable Syringe isintended for aspirationand injection of fluids. | Comment 1. |
| Principle ofoperation | Normal | Normal | Identical |
| Needle length | 3/8", 1/2", 1" | 3/8", 5/8", 3/4", 1" | Comment 2. |
| Needle gauge | 23G, 24G, 25G, 26G,27G, 28G, 29G, 30G | 23G, 24G, 25G, 27G | Comment 3 |
| Syringecapacity | 0.05ml, 0.10ml, 0.20ml,0.25ml, 0.30ml, 0.40ml,0.50ml, 1.0ml | 0.05ml, 0.10ml, 0.50ml, | Comment 4 |
| ReusePrevention(Safety)Feature | Auto-disabled, preventssyringe re-use | Auto-disabled,prevents syringere-use | Identical |
| Lubricant forbarrel | Silicone oil | Silicone oil | Identical |
| Barreltransparency | Transparent and clear | Transparent and clear | Identical |
| Gradationslegibility | Legible | Legible | Identical |
| Material | Barrel: PP | Barrel: PP | Comment 5 |
| Plunger: PP | Plunger: PP | ||
| Piston: Latex Free | Piston: rubber | ||
| (Polyisoprene Rubber) | Needle: stainless steel | ||
| Needle: stainless steel | |||
| Performance | Conform to ISO7886-3and ISO7886-1,ISO9629, ISO7864 | Conform to ISO7886-3and ISO7886-1,ISO9629, ISO7864 | Identical |
| Biocompatibility | Conform to ISO10993 | Conform to ISO10993 | Identical |
| Labeling | Meet the requirementsof 21CFR Part 801 | Meet the requirementsof 21CFR Part 801 | Identical |
| Sterility | EO sterilization 10-6 | EO sterilization 10-6 | Identical |
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Discussions of differences in technological characteristics
Comment 1:
The indications for use are similar for both devices (to the extent that both devices are intended for aspiration and injection of fluids for medical purposes). The predicate device defines that the device is for general use. The subject device is specifically used for vaccine administration, which is included in the scope of general use. In addition, the subject device includes a statement regarding the locking mechanism to prevent re-use. This mechanism is included in the predicate design, but is not included in the indications for use statement. The differences to the indications for use statement between the predicate and the subject device are acceptable.
Comment 2, 3 and 4:
The specifications of the proposed device and predicate device are different; however, both of them comply with the same recognized standards. The different sizes of needle are addressed through performance testing.
Comment 5:
The piston used the new technology material to replace the traditional rubber material for less toxicity (Polyisoprene Rubber). The safety testing report of biocompatibility and function performance testing report demonstrates that the change does not negatively impact safety and performance.
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Non-Clinical Testing
Functional Performance Testing
The AUTO DISABLE SYRINGE described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
ISO 7864:2016, Sterile hypodermic needles for single use - Requirements and test methods
- . Fragmentation test
- . Determination of flow rate
- . Lubricant: Penetration force and drag force
- . Bonding strength
ISO 7886-3, sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization and ISO7886-1, sterile hypodermic syringes for single use - Part 1: Syringes for manual use
- . Limits for acidity and alkalinity
- . Limits for extractable metals
- . Lubricant: Penetration force and drag force
- . Tolerance on nominal capacity
- Graduated scale ●
- . Barrel- dimensions and flanges
- Plunger stopper and assembly - fitness of stopper /plunger in barrel
- Integrated needle
- . Sharps protection features
- . Dead space
- Freedom from air and liquid leakage ●
- Auto-disable syringe feature .
ISO9626, Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods
- Limits for acidity and alkalinity
- designated metric size ●
- Stiffness .
- Resistance to breakage ●
- Resistance to corrosion .
Sterility, Shipping and Shelf-Life
- . EO sterilization validation and package validation conducted in accordance with ISO11135:2014, ISO11607-1:2019, ISO11607:2019
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- . Sterilant residuals were evaluated per ISO10993-7:2008. Average daily dose to patient of EO less than 4mg/device and ECH less than 9mg/device
- . Package integrity testing, after environmental conditioning and simulated transportation in accordance with ASTM D4169-16, was conducted on the final, packaged, and sterile devices. All packaging deemed acceptable for protection of product and sterility maintenance.
- . Sterile Barrier Packaging Testing performed on the proposed device:
- o Seal strength ASTM F88/F88-15
- o Visual Inspection ASTM F 1886-16
- o Dye penetration ASTM F1929-15
- . Shelf life of 5 years is validated using the FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Biocompatibility Testing (ISO10993-1:2018)
In accordance with ISO 10993-1, the syringe is classified as: Externally Communicating Device, Blood Path Indirect, Limited Contact (<24 hours). The following testing was conducted:
- . Cytotoxicity (per ISO10993-5:2009)
- . Sensitization (per ISO10993-10:2014)
- Irritation (per ISO10993-10:2017) .
- Acute Systemic Toxicity (per ISO10993-11:2017) .
- Pyrogenicity (per ISO10993-4:2017) ●
- Hemocompatibility (per ISO10993-4:2017) .
- . Particulate matter ( per USP<788>)
Conclusions
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The AUTO DISABLE SYRINGE is substantially equivalent to BD SoloShot Mini Syringe/ BD Auto Disable Syringe with respect to the indications for use 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).