The Platelet Concentrate Separation kit is designed for use in the clinical laboratory or intra-operatively at point of care, for the safe and effective preparation of platelet poor plasma and platelet concentrate from a small sample (50-60 ml) of whole blood.

The plasma and concentrated platelets can be used for diagnostic tests.

Device Description

The platelet concentrate separation kit aids separation of the patient's own blood components by density through the use of a centrifuge. The platelet concentration kit permits platelet rich plasma to be rapidly prepared from a small volume of the patient blood that is drawn at the time of treatment.

Kit Components: 18 gauge x 1" x 12" apheresis needle, 16 gauge centesis needle 1 ¼" catheter, 60 ml piston syringe, 30 ml piston syringe, 1 ml piston syringe, petri dish, rubber tubing tourniquet, gauze pad, alcohol pad, adhesive tape, silicone tube, volume gauge, PETG tray with sealed Tyvek® lid

AI/ML Overview

The provided document (K021927) is a 510(k) premarket notification for a medical device. It does not describe acceptance criteria and a study that proves the device meets those criteria in the typical sense of a clinical trial for diagnostic performance. Instead, it details a non-clinical study for substantial equivalence to a predicate device.

Here's an analysis based on the information provided, tailored to your request:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify formal "acceptance criteria" with numerical thresholds for performance. The non-clinical testing focused on demonstrating functional equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Produces platelet rich plasma (PRP) from whole blood.	Met: The device aids separation of blood components to prepare PRP.
Produces PRP at a concentration equal to or greater than the predicate device.	Met: Platelet count results verified the modified device produced platelet rich plasma at a concentration that was equal to or greater than the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document mentions "bovine and human blood" but does not quantify the number of samples or individuals studied.
Data Provenance: The study was a "Non-Clinical Testing" and "Laboratory testing" performed to compare efficiency.
- Country of Origin: Not specified, but likely in the US as the applicant is Biomet, Inc. in Indiana.
- Retrospective or Prospective: Not explicitly stated, but typically these types of laboratory comparison studies are prospective, conducted for the purpose of the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This was a laboratory comparison study of a device's mechanical function (blood component separation and concentration), not an interpretive diagnostic device requiring expert human review to establish ground truth for a test set. The "ground truth" here would be the measured platelet concentration.

4. Adjudication Method for the Test Set

Not applicable, as there was no subjective interpretation or diagnostic outcome requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study was a non-clinical laboratory test comparing the functional output (platelet concentration) of the new device to a predicate device. The document explicitly states "Clinical Testing: Not Applicable."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is a physical kit for blood processing, not an algorithm. Therefore, "standalone" algorithm performance is not relevant. The device itself operates autonomously once initiated to separate blood components. Its performance was tested directly by measuring platelet concentration.

7. The Type of Ground Truth Used

The ground truth used was measured platelet count/concentration. This is an objective laboratory measurement, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This device is a physical kit, not an AI/ML algorithm that requires a "training set." The engineering and design of the kit would be based on scientific principles of centrifugation and blood component density, rather than an iteratively trained model.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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KO21922)

Summary of Safety and Effectiveness

PCCS Platelet Concentrate Separation Kit

Applicant/Sponsor: Biomet, Inc. P.O. Box 587 56 East Bell Drive Warsaw, IN 46581-0587
Contact Person: Lonnie Witham Phone: (574) 267-6639 Fax: (574) 372-1683

Trade Name: Platelet Concentrate Separation Kit

Common name: Centrifuge accessories

Classification Name: Centrifuges (micro, ultra, refrigerated) for clinical use accessory kit

Legally Marketed Devices to Which substantial Equivalence is Claimed: The modified device is substantially equivalent to the original Implant Innovations CelSep® Centrifuge System (K994148) for producing platelet rich plasma from 50-60 ml of whole blood.

Device Description

Intended Use:

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Summary of Technologies:

The device has the same technological features as other tabletop centrifuge systems previously cleared by the FDA via the 510(k) process. This kit consists of standard legally marketed devices including syringes, needles, gauze, adhesive tape, alcohol pad, rubber tubing tourniquet, petri dish, and centrifuge blood processing disposable container used to draw and process a small sample of whole blood. The blood is spun in a centrifuge to produce platelet rich plasma. The centrifyae system has similar technological features as the predicate device cleared in K994841.

Non-Clinical Testing:

Laboratory testing was performed to compare the efficiency of the modified device with the predicate device in producing platelet rich concentrate. A functional test was performed on bovine and human blood and the platelet count results verified that the modified device produced platelet rich plasma at a concentration that was equal to or greater than the predicate device.

Clinical Testing: Not Applicable

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned within a circular border. Encircling the bird within the border are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

2098 Ga
Rockville

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Lonnie Witham Biomet, Inc. P.O. Box 587 56 East Bell Drive Warsaw, Indiana 46581-0587

Re: K021927

Trade/Device Name: Platelet Concentrate Separation Kit Regulation Number: 21 CFR § 862.2050 and 21 CFR § 880.5860 Regulation Name: General Purpose Laboratory Equipment and Piston syringes

JUL 12 2002

Regulatory Class: I and II Product Code: LXG and FMF Dated: June 11, 2002 Received: June 12, 2002

Dear Mr. Witham:

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. Iisting 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.

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. 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 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/dsmaldsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

510(k) Number K021927

Device Name: Platelet Concentrate Separation Kit for CelSep® Centrifuge System

Indications for Use:

The plasma and concentrated platelets can be used for diagnostic tests.

(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)

Suite MichaelO FOR J. BAUTISTA

(Division Sign-Off) Division of Clinical Laboratory De 510(k) Number -

Regulation Number and Section

§ 862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use.

(a)
Identification. General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.(b)
Classification. Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.