(85 days)
For use in venous blood collection
a tubular stainless steel device sharpened at both ends, one end to withdraw blood, and the other end to be threaded into a needle holder which is used to guide the needle into an evacuated blood collection tube.
This device, the Greiner Vacuette® Multi-sample needle (K973620), is a Class II medical device that received 510(k) clearance based on substantial equivalence to an existing predicate device, Gainor Medical's Suresharp® needles (K950159).
Therefore, this submission does not contain acceptance criteria in the traditional sense of performance metrics with thresholds that the device must meet through a new study. Instead, the "acceptance criteria" are implicitly met by demonstrating that the device is identical in materials and intended use to a previously cleared device.
Here's a breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Same intended use as predicate device (Gainor Medical's Suresharp® needles - K950159) | For use in venous blood collection (identical to predicate device's intended use). |
| Same material composition as predicate device | Needle: Stainless steel (same as Gainor needle) Hub: Polypropylene (same as Gainor needle) Sleeve: Rubber (same as Gainor needle) Needle Shield: Polypropylene (same as Gainor needle) |
| Purchased from the same supplier as the predicate device | Needles are purchased from the same supplier in Japan as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No new performance testing in a "test set" was conducted or reported for this 510(k) submission.
- Data Provenance: Not applicable. The submission relies on a statement of material and supplier identity, not new data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. As no new "test set" was evaluated, no experts were needed to establish ground truth for performance.
4. Adjudication Method for the Test Set
- Not applicable. No "test set" was evaluated.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No. This type of study is not relevant for a device seeking clearance based on substantial equivalence of materials and intended use.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a manual blood collection needle; it does not involve an algorithm or AI.
7. The Type of Ground Truth Used
- The "ground truth" for this submission is based on material composition and supplier identity, verified through a statement by the manufacturer. The core assumption is that if the materials and supplier are the same as a legally marketed predicate device, the performance will be substantially equivalent.
8. The Sample Size for the Training Set
- Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm or a device requiring such data.
9. How the Ground Truth for the Training Set was Established
- Not applicable. No "training set" was used.
Summary of the "Study" (Demonstration of Substantial Equivalence):
The "study" in this case is a comparative analysis of device characteristics against a predicate device, rather than a clinical or performance study involving human subjects or data analysis. The manufacturer, Greiner Meditech, Inc., established substantial equivalence by reporting that their Vacuette® Multi-sample needle:
- Has the same intended use (venous blood collection) as the predicate device (Gainor Medical's Suresharp® needles - K950159).
- Is made of the same materials for each of its components (stainless steel for the needle, polypropylene for the hub and shield, rubber for the sleeve) as the predicate device.
- Is purchased from the same supplier in Japan as the predicate device, further supporting the claim of identicality.
This approach is common for straightforward Class II devices where the risks are well-understood and the device is a direct copy or very minor modification of an already cleared product. The FDA's acceptance of this submission indicates they found these claims sufficient to establish substantial equivalence.
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DEC 17 1997
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I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Greiner Meditech, Inc. ("Greiner") is submitting a 510(k) premarket notification for it's Greiner Vacuette® Multi- sample needle. The Vacuette® Multi- sample needle is a tubular stainless steel device sharpened at both ends, one end to withdraw blood, and the other end to be threaded into a needle holder which is used to guide the needle into an evacuated blood collection tube..
Greiner is claiming substantial equivalence to Gainor Medical's Suresharp® needles (K950159). Both multi-sample needles have the same intended use and contain the same material. The material of the Greiner needle is stainless steel and is the same material used for the Gainor needle. The material of the hub for both needles is made from polypropylene. The sleeve covering the short end of the needle is made from rubber. The needle shield is made from polypropylene. The equivalency of the needles is certified by a statement that the needles are the same and purchased from the same supplier in Japan.
Greiner's 510(k) has been submitted on Monday, September 22, 1997, by Douglas L. Harris, Managing Director, Greiner Meditech, Inc., 260 Gateway Drive, Suite 17A, Bel Air, Maryland, 21014 (410-836-8228).
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure, with flowing lines suggesting movement or progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Douq Harris Manaqinq Director Greiner Meditech, Incorporated 260 Gateway Drive, Suite 17A Bel Air, Maryland 21014
DEC 17 1997
Re : K973620 Vacuette Multi-Sample Needle Trade Name: II Requlatory Class: Product Code: FMI Dated: September 18, 1997 September 23, 1997 Received:
Dear Mr. Harris:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Harris
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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 ons regaration theation" (21 CFR 807.97) Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Timo 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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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known) _ K 9 7 34 20
Device Name: VACUETTE® Multi-sample Needle
Indications for Use: For use in venous blood collection
Labaux Cucinol
(Division Sign-Off) Division of Dental, Info and General Hospi 510(k) Number
Prescription Use X
18:00
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
§ 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).