(85 days)
The intended use of the Patient Safe Syringe™ is to aspirate fluid and inject fluids into the body. Additionally, the unique design of the syringe protects the luer tip from contact contamination prior to injection, thus reducing the risk of medication contamination and bloodstream infections resulting from luer tip contamination.
The Patient Safe Syringe™ is a 3 piece piston syringe consisting of a calibrated hollow barrel and a movable plunger with a plunger seal. One end of the barrel has a male connector (nozzle) which permits attachment to a female (hub). The collar on the luer end is slightly extended to protect and prevent contact contamination of the luer tip and is compatible with most luer fittings.
Here's an analysis of the provided text regarding the Patient Safe Syringe™, focusing on acceptance criteria and study details.
Important Note: The provided document is a 510(k) summary, which is a premarket notification for a medical device. These summaries typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed standalone performance studies with specific acceptance criteria as might be found for novel technologies or software. This particular document makes no mention of AI or machine learning.
The document emphasizes a comparison to a predicate device and states that "The manual operation, similar design and identical materials between the predicate device and the subject device do not raise new issues of safety and effectiveness." This strongly suggests that a formal study with quantitative acceptance criteria, in the way one might expect for a diagnostic or AI device, was not conducted or is not necessary for this type of submission. The focus is on the design change (the collar) and its protective function.
Acceptance Criteria and Device Performance (Based on provided text)
Given the nature of the 510(k) summary for a piston syringe and the lack of specific performance quantitative metrics, the "acceptance criteria" are implied by the claim of substantial equivalence and the intended benefit of the design change.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied from comparison) |
|---|---|
| Safe and Effective for fluid aspiration and injection. | Functions equivalently to the predicate Nipro Disposable Syringes (K030683) for fluid aspiration and injection, due to similar design, manual operation, and identical materials. |
| Protects the luer tip from contact contamination prior to injection. | The unique design of the collar at the luer end is described as "slightly extended to protect and prevent contact contamination of the luer tip." |
| Reduces the risk of medication contamination and bloodstream infections from luer tip contamination. | The design change is stated to "thus reducing the risk of medication contamination and bloodstream infections resulting from luer tip contamination." This is presented as an intended benefit of the luer tip protection, rather than a quantitatively proven outcome from a clinical study within this submission. |
| Does not raise new issues of safety and effectiveness compared to the predicate device. | The submission explicitly states: "The manual operation, similar design and identical materials between the predicate device and the subject device do not raise new issues of safety and effectiveness." |
Study Details (Based on provided text)
The document does not describe a formal study with a test set, ground truth, experts, or statistical analysis in the way modern AI/ML device submissions would. The evaluation appears to be based on design comparison and engineering principles rather than clinical trials or reader studies.
- Sample size used for the test set and the data provenance: Not applicable. No test set or associated data is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No expert review or ground truth establishment for a test set is described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication method is described.
- 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 device is a mechanical piston syringe; there is no AI component or human-in-the-loop performance measurement.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm or software component.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No formal ground truth for a performance study is described. The "ground truth" for this submission is essentially the predicate device's established safety and effectiveness, and the engineering rationale for the modification.
- The sample size for the training set: Not applicable. No training set is mentioned as there is no AI/ML component.
- How the ground truth for the training set was established: Not applicable. No training set or ground truth establishment is mentioned.
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Retractable Technologies, Inc. 510(k) Submission Date: 09/18/07
K072654
es, Inc.
/18/07
/ of /
PREMARKET NOTIFICATION 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FOR PATIENT SAFE SYRINGE™ (21 CFR 807.92)
| Contact Person: | Rhonda WellsRegulatory Affairs Manager |
|---|---|
| Date of Summary Preparation: | September 18, 2007 DEC 1 4 2007 |
| Trade Name: | Patient Safe Syringe™ |
| Common Name: | Piston Syringe |
| Classification Name: | Piston Syringe |
| Device Classification: | Class II |
| Legally Marketed Substantially Equivalent Device: | Nipro Disposable Syringes (K030683) |
| Description of Device: | The Patient Safe Syringe™ is a 3 piece piston syringe consisting of a calibrated hollow barrel and a movable plunger with a plunger seal. One end of the barrel has a male connector (nozzle) which permits attachment to a female (hub). The collar on the luer end is slightly extended to protect and prevent contact contamination of the luer tip and is compatible with most luer fittings. |
| Intended Use: | The intended use of the Patient Safe Syringe™ is to aspirate fluid and inject fluids into the body. Additionally, the unique design of the syringe protects the luer tip from contact contamination prior to injection, thus reducing the risk of medication contamination and bloodstream infections resulting from luer tip contamination. |
| Comparison of Technical Characteristics: | The subject Patient Safe Syringe™ and the Nipro predicate device are very similar in design and technological characteristics and identical in materials. |
| Substantial Equivalence: | The Patient Safe Syringe™ is different from the Nipro Disposable Syringe only in the design of the collar at the luer end of the syringe. The manual operation, similar design and identical materials between the predicate device and the subject device do not raise new issues of safety and effectiveness. |
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Image /page/1/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally oriented. The words are stacked on a single line.
DEC 1 4 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Rhonda Wells Regulatory Affairs Manager Retractable Technologies, Incorporated 511 Lobo Lane Little Elm, Texas 75068-0009
Re: K072654 Trade/Device Name: Patient Safe Syringe™ Regulation Number: 21 CFR 880,5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: September 19, 2007 Received: September 20, 2007
Dear Ms. Wells:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
I
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Page 2 - Ms. Wells
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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Cintin D, mmuk for
Chin Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K022654
Device Name: Patient Safe SyringeTM
Indications for Use:
The intended use of the Patient Safe Syringe™ is to aspirate fluid and inject fluids into the body. Additionally, the unique design of the syringe protects the luer tip from contact contamination prior to injection, thus reducing the risk of medication contamination and bloodstream infections resulting from luer tip contamination.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Antim Vihm
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
§ 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).