(110 days)
The intended function of the SECUREGARD® Retractable Safety Syringe is to provide a safe and reliable method of intramuscular and subcutaneous injection of medication into a patient. The syringe should not be used for blood collection. The SECUREGARD® Retractable Safety Syringe is also intended to prevent needle stick injuries. In addition, when the syringe user breaks the plunger, reuse of the syringe is prevented.
The SECUREGARD is a sterile, single-use, disposable hypodermic syringe with sharps injury and reuse prevention features. It is manufactured in sizes of 0.5, 1, 2, 2.5, 3, 5, 10 and 20 mL volume.
The provided document is about the SECUREGARD® Retractable Safety Syringe and describes its safety and effectiveness. However, it does not contain acceptance criteria or details of a study that proves the device meets specific acceptance criteria in the format requested.
The document is a 510(k) summary (K012121) from October 24, 2201, which primarily focuses on demonstrating substantial equivalence to a predicate device (SOLOGARD® Locking Plus Syringe).
Here's what can be extracted and why other requested information is not available in the provided text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sharps injury prevention feature: Easily and safely activated by the user. | "The sharps injury prevention feature was demonstrated to be easily and safely activated by the user." |
| Sharps protection feature: Effectively shields the needle. | "the needle was effectively shielded by the sharps protection feature." |
| Reuse prevention: Plunger breaks when user breaks it. | "when the syringe user breaks the plunger, reuse of the syringe is prevented." |
Critique: These are more descriptive statements of functionality rather than quantitative "acceptance criteria" with specific thresholds (e.g., "95% of users can activate safety feature within X seconds" or "needle fully retracted in Y% of uses").
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document states that the safety and effectiveness were "demonstrated" but does not specify how (e.g., in a formal study) or the sample size, data provenance, or study design.
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):
- Not provided. This type of information is not relevant for a mechanical device like a syringe and is not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided. Not applicable as no formal expert adjudication process is described for this type of device.
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 device is a retractable safety syringe, not an AI-powered diagnostic tool. Therefore, an MRMC study and AI performance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the functional claims, the "ground truth" implicitly relies on direct observation or testing of the syringe's physical operation by undefined evaluators. There is no mention of pathology, expert consensus, or outcomes data in the context of proving the safety features.
8. The sample size for the training set:
- Not applicable. This is a mechanical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI model.
In summary: The provided text is a regulatory submission for a medical device (syringe) focused on demonstrating substantial equivalence to a legally marketed predicate. It reports on the device's functional characteristics related to safety (sharps injury and reuse prevention) but lacks the detailed experimental design, acceptance criteria, and performance metrics typically found in a study report for more complex diagnostic or AI-driven devices.
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K012/21
OCT 2 4 2001
October 17, 2001
Page 1 of 1
(510k) Summary of Safety and Effectiveness
Pursuant to Section 510(k) of the Federal Food, Drug and Cosmetic Act, Safety and Effectiveness information is enclosed for the following device:
| Device Name: | SECUREGARD® Retractable Safety Syringe |
|---|---|
| Trade Name: | SECUREGARD® Syringe |
| Common Name: | Safety Syringe |
| Classification name: | Piston Syringe / Anti-Stick Syringe |
| Device Class: | Class II |
| Classification Code: | MEG |
| Performance Standard: | None established. |
| Safety and Effectiveness: | No new issues safety and effectiveness as relating to hypodermicsyringes. The sharps injury prevention feature was demonstratedto be easily and safely activated by the user, and the needle waseffectively shielded by the sharps protection feature. |
| Facility Address: | SafeGard Medical Systems (Hungary) KFTJoszéréncsét tér 15, H-3608Farkaslyuk, Hungary |
Establishment Registration Number: 9616482
Indications for Use: The intended function of the SECUREGARD® Retractable Safety Syringe is to provide a safe and reliable method of intramuscular and subcutaneous injection of medication into a patient. The syringe should not be used for blood collection. The SECUREGARD® Retractable Safety Syringe is also intended to prevent needle stick injuries. In addition, when the syringe user breaks the plunger, reuse of the syringe is prevented.
The SECUREGARD® Retractable Safety Syringe is Substantial Equivalence: substantially equivalent to the SOLOGARD® Locking Plus Syringe. The SECUREGARD is a sterile, single-use, disposable hypodermic syringe with sharps injury and reuse prevention features. It is manufactured in sizes of 0.5, 1, 2, 2.5, 3, 5, 10 and 20 mL volume.
Contact Information:
Pat Grant Jr. Director Regulatory Affairs SafeGard Medical Products, Inc 52 Dragon Court Woburn, MA 01801 Tel. (781) 935 2275 Fax (781) 935 8424
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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
OCT 2 4 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SafeGard Medical Products, Incorporated C/O Mr. Mike Dayton BioMed Research, Incorporated 14802 Hadleigh Way Tampa, Florida 33624
Re: K012121
Trade/Device Name: SECUREGARD® Retractable Safety Syringes Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: September 21, 2001 Received: October 1, 2001
Dear Mr. Dayton:
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 releved above and had in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Andelheinente, of to do roons one ic Act (Act) that do not require approval of a premarket the rederal I ood, Drag, Drag, therefore, market the device, subject to the general apper of a upprovisions 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 (1 NI ), It ina) of each 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 statutes and regulations administered by other Federal agencies.
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Page 2 - Mr. Dayton
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
[signature]
Tim y A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ko/2121
Indications for Use Statement
510k Number (if known): ______________________________________________________________________________________________________________________________________________________ K012121
Device Name: SECUREGARD® Retractable Safety Syringe
Indications For Use:
The intended function of the SECUREGARD® Retractable Safety Syringe is to provide a safe and reliable method of intramuscular and subcutaneous injection of medication into a patient. The syringe should not be used for blood collection. The SECUREGARD® Retractable Safety Syringe is also intended to prevent needle stick injuries. In addition, when the syringe user breaks the plunger, reuse of the syringe is prevented.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Patrice Crescent
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices F 1 (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).