The GPS™ Platelet Separation kit is designed for use in the clinical laboratory or intraoperatively 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 GPSTM separation kit aids separation of the patient's own blood components by density through the use of the GPS™-Thermo International Equipment Company (IEC) centrifuge. The GPS™ separation kit permits platelet rich plasma to be rapidly prepared from a small volume of the patient's blood that is drawn at the time of treatment.

Kit Components: 18 gauge x 1" x 12" apheresis needle, 16 gauge centesis needle 1 1/4" 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, 50 ml bottle of anticoagulant citrate dextrose solution, U.S.P., Solution A (ACD-A).

AI/ML Overview

The provided document is a 510(k) clearance letter for a medical device called the GPS™ Platelet Separation Kit with Anticoagulant ACD-A. This document describes the device, its intended use, and the basis for its clearance, which is substantial equivalence to a predicate device.

It is crucial to understand that a 510(k) clearance does not necessarily involve a study with acceptance criteria in the same way a de novo or PMA submission might, especially for diagnostic AI/ML devices. Instead, it focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device. The "acceptance criteria" here are implicitly tied to the performance of the predicate device.

The request for information (table format, sample sizes, experts, adjudication, MRMC, standalone, ground truth type and training set details) is typically applicable to the validation of AI/ML-driven diagnostic devices. This 510(k) document is for a physical medical device for preparing blood components, not an AI/ML diagnostic system. Therefore, most of the requested information regarding AI/ML device validation is not present in this document.

However, I can extract the relevant information from the provided text as accurately as possible given the context of a 510(k) for a non-AI/ML device.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

Since this is a substantial equivalence claim for a physical kit (not an AI/ML diagnostic), the "acceptance criteria" are implied by demonstrating that the device performs comparably to its predicate device in its intended function: separating blood components to produce platelet-rich plasma (PRP).

Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (as tested for predicate)
Produce platelet-rich plasma (PRP)	Produced platelet rich plasma at a concentration that was equal to or greater than other devices cleared for market.
Safe preparation of platelet poor plasma and platelet concentrate from whole blood	Kit is "designed for safe and effective preparation of platelet poor plasma and platelet concentrate."
Functional testing on human and bovine blood	Functional testing on bovine and human blood was performed.
Anticoagulant functionality	Original manufacturer performed relevant testing for the anticoagulant.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is detailed under "Non-Clinical Testing" within the 510(k) submission for the predicate device (K021927). The current 510(k) (K030555) references these earlier tests to support its substantial equivalence claim, particularly for the physical separation kit components. The anticoagulant (ACD-A) specifically had relevant testing performed by its original manufacturer, Cytosol Laboratories, Inc.

Detailed Information Request (where applicable to this type of device):

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated in terms of a specific "test set" size. The document mentions "small sample (50-60 ml) of whole blood" as the input for the device, and "functional testing on bovine and human blood." The number of subjects or samples used in the predicate device's testing is not provided in this summary.
- Data Provenance: Not specified (e.g., country of origin). The testing was "functional testing on bovine and human blood," indicating some human samples were likely involved, but specifics are absent in this summary. The anticoagulant testing was done by "Cytosol Laboratories, Inc."
- Retrospective or Prospective: Not specified.
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 applicable/Not provided. This device is a component separation kit. Its performance is assessed by quantitative measurements (e.g., platelet count, separation efficiency), not by expert interpretation of diagnostic images or data. Therefore, the concept of "experts establishing ground truth" in the diagnostic AI/ML sense is not relevant here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. As above, this is not an AI/ML diagnostic device requiring adjudication of interpretations.
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-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-only device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this type of device, the "ground truth" would be quantitative laboratory measurements of blood component concentrations (e.g., platelet count, plasma volume, purity of separation) compared against expected or established values for effective PRP preparation. It is based on analytical and functional performance criteria, not expert interpretation of pathology or outcomes data in the usual sense.
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device that requires a training set.

Summary

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K030555
APR 11 2003

Summary of Safety and Effectiveness

GPS™ Platelet Separation Kit with Anticoagulant ACD-A

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 E-mail: lonnie.witham@biometmail.com

Trade Name: GPS™ Platelet Separation Kit with Anticoagulant ACD-A

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 predicate device is the PCCS Platelet Concentrate Separation Kit previously cleared by 510(k) notification (K021927 - July 12, 2002, Biomet Inc.) Piston syringes were also previously cleared as Bone Graft Delivery System by 510(k) notification (K021071 -July 1, 2002)

The anticoagulant is being included in the kit for the convenience of the user of the predicate device procured anticoagulant separately.

Device Description

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Intended Use:

The GPS™ Platelet Separation Kit is designed for use in the clinical laboratory or intraoperatively 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.

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 accessory kit consists of standard 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 centrifuge system has similar technological features as the predicate device cleared in K994841.

Non-Clinical Testing:

The original manufacturer. Cytosol Laboratories. Inc. performed relevant testing for the anticoagulant.

Biomet testing was submitted in the predicate 510(k) notification (K021927) including functional testing on bovine and human blood. The platelet count results verified that the predicate device produced platelet rich plasma at a concentration that was equal to or greater than other devices cleared for market.

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Image /page/2/Picture/1 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, often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 1 1 2003

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

Re: K030555

Trade/Device Name: GPS™ Platelet Separation Kit with Anticoagulant ACD-A Regulation Number: 21 CFR § 862.2050 Regulation Name: General purpose laboratory equipment labeled or promoted for a specific medical use Regulatory Class: I Product Code: JQC Dated: February 18, 2003 Received: February 20, 2003

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of In Vitro Diagnostic Device Evaluation and Safety has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings and Precautions section of the device's labeling:

The safety and effectiveness of this device for in vivo indications for use has not been established.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

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Page 2 - Mr. Lonnie Witham

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

If you desire specific information about the application of other labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 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/dsma/dsmamain.html.

Sincerely yours.

A. Dutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Device Name: GPSTM Platelet Separation Kit with Anticoagulant ACD-A

Indications for Use:

(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)

Over-The-Counter-Use (Optional Format 1-2-96)

Josephine Bautista

(Division Sign-Off) Division of Clinical Laboratory Device 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.