(150 days)
The Ritract Safety Syringe is a sterile, single-use, disposable, nonreusable, auto-retracting safety syringe which is intended for injection of fluids into the body, while reducing the risk of sharps injury and the potential for syringe reuse.
The Ritract Safety Syringe is a sterile, single-use, disposable, nonreusable, 3mL, 5mL, 10ml, auto-retracting safety syringe with a standard luer lock needle connection.
The provided K060002 510(k) premarket notification for the Ritract Safety Syringe does not contain the specific details about acceptance criteria or a dedicated study that proves the device meets such criteria.
This document is a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a detailed performance study with explicit acceptance criteria. The equivalence is primarily based on:
- Mode of operation: The Ritract Safety Syringe and the predicate (BD Integra Spring Based Syringe K011103) both use the action of the plunger bottoming out to release a compressed spring, retracting the needle.
- Function: Both devices are auto-retracting safety syringes intended for injecting fluids while reducing sharps injury and preventing reuse.
- Materials used, packaging, and manufacturing processes: The document states these are also equivalent.
Therefore, I cannot populate the requested table or answer most of the questions using the provided text. The submission implies that by being substantially equivalent to a predicate device, it inherently meets the performance standards expected for such devices, rather than establishing new, explicit acceptance criteria and proving them through a dedicated study within this document.
Here's what can be inferred or explicitly stated from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative metrics (e.g., success rate percentage for needle retraction). The implicit acceptance criterion is that the device functions to auto-retract the needle upon full plunger depression, similar to the predicate.
- Reported Device Performance: The document states, "The Ritract Safety Syringe also uses the action of the plunger bottoming out to release the compressed spring. In the case of the Ritract Syringe the spring is held in compression by a collar system which as the plunger bottoms out the interaction of the plunger profile and the collar activates the release of the spring and draws the needle into the barrel of the syringe with no protrusion of the needle tip from the device." This describes the mechanism and successful retraction, but no quantitative performance data (e.g., 100% success rate across X number of trials) is provided in this summary.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned; no specific performance study data is included in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no specific test set and ground truth establishment methodology are described in this regulatory submission.
4. Adjudication method for the test set:
- Not applicable.
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 not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI/software device.
7. The type of ground truth used:
- Not applicable, as no formal ground truth for a test set is described. The "truth" in this context is the successful demonstration of the device's mechanism of action (needle retraction) as described, which is considered equivalent to the predicate.
8. The sample size for the training set:
- Not applicable, as this is not an AI/software device with a distinct training set.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of Device and Equivalence Statement:
The Ritract Safety Syringe is a sterile, single-use, disposable, non-reusable, 3mL, 5mL, 10mL auto-retracting safety syringe with a standard luer lock needle connection. It is indicated for the injection of fluids into the body, while reducing the risk of sharps injury and the potential for syringe reuse.
The submission claims substantial equivalence to the BD Integra Spring Based Syringe (K011103) based on:
- Similar mode of operation (plunger bottoming out activates a mechanism to retract the needle).
- Similar function (auto-retracting safety syringe).
- Similar materials, packaging, and manufacturing processes.
The 510(k) process primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive de novo clinical trials or detailed performance studies with explicit, quantitative acceptance criteria in the summary document. The FDA's issuance of the 510(k) clearance (JUN - 2 2006) indicates they agreed with the substantial equivalence claim.
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JUN - 2 2006
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510(k) PREMARKET NOTIFICATION SUMMARY
Submitter Details: Ritract Limited 1. ABN 28 106 353 253 Level 17, 201 Miller Street North Sydney, NSW 2060 +61 2 8923 2512 Phone:
Mr. Rupert Northcott 2. Contact Person: Managing Director, Ritract Limited Level 17, 201 Miler Street North Sydney, NSW 2060 Australia
+61-2 8923 2511 Phone: +61 2 8923 2525 Fax: Email : rupert@ritract.com
Name of the device: 3.
Ritract Safety Syringe Proprietary Name: Common/Usual Name: Syringe Hypodermic Piston Syringe Classification Name:
Predicate Device(s): 4.
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5. Device Description
The Ritract Safety Syringe is a sterile, single-use, disposable, nonreusable, 3mL, 5mL, 10ml, auto-retracting safety syringe with a standard luer lock needle connection.
6. Indications for Use:
The Ritract Safety Syringe is a sterile, single-use, disposable, nonreusable, auto-retracting safety syringe which is intended for injection of fluids into the body, while reducing the risk of sharps injury and the potential for syringe reuse.
Summary of the technological characteristics of our 7. device compared to the predicate device:
The Ritract Safety Syringe operates in the same fashion as the BD Integra 3ml Syringe. The needle is assembled by the user onto the syringe, the user draws the required fluid into the barrel as indicated by the graduation marks by drawing back the plunger, and the user injects the fluid by pushing the plunger forward till it bottoms out in the barrel. In both devices when the plunger bottoms out in the barrel this action activates a simple mechanism which releases the compressed spring and draws the needle back up into the barrel of the syringe with no protrusion of the syringe tip from the device.
In the case of the BD Integra Syringe the mechanism which releases the compressed spring is as follows: The plunger contains a tool which as it bottoms out in the barrel travels through the piston seal and pierces a hub on the dedicated BD Integra Needle which releases the spring drawing the needle fully up inside the plunger.
The Ritract Safety Syringe also uses the action of the plunger bottoming out to release the compressed spring. In the case of the Ritract Syringe the spring is held in compression by a collar system which as the plunger bottoms out the interaction of the plunger profile and the collar activates the release of the spring and draws the needle into the barrel of the syringe with no protrusion of the needle tip from the device.
8. Equivalence
The Ritract Safety Syringe is substantially equivalent to the BD Integra Syringe in terms of the mode of operation, function, materials used, packaging, manufacturing processes and performance.
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services, USA. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 2 2006
Mr. Rupert Northcott Managing Director Ritract, Limited Level 17, 201 Miller Street North Sydney, NSW 2060 AUSTRALIA
Re: K060002
Trade/Device Name: Ritract Safety Syringe Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: May 12, 2006 Received: May 16, 2006
Dear Mr. Northcott:
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.
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Page 2 - Mr. Northcott
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.
Chiu 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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Indications for Use Statement
510(k) Number (if known):
Device Name:
Ritract Safety Syringe
Indications for Use:
The Ritract Safety Syringe is a sterile, single-use, disposable, nonreusable, auto-retracting safety syringe which is intended for injection of fluids into the body, while reducing the risk of sharps injury and the potential for syringe reuse.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use_ (Optional Format 1-2-96)
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-(-11) of Anasthesiology, General Hospital, on Control, Dental Devices
Number: K460042
§ 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).