(49 days)
No
The description focuses on a physical kit and centrifuge for blood component separation based on density, with no mention of AI or ML technologies.
No.
The device is used to prepare platelet poor plasma and platelet concentrate for diagnostic tests, not for direct therapeutic intervention.
No.
Justification: The device is designed to prepare platelet poor plasma and platelet concentrate, which "can be used for diagnostic tests," but the device itself does not perform diagnostic tests or provide diagnostic information.
No
The device description explicitly lists multiple hardware components included in the kit, such as needles, syringes, tubing, and a petri dish. It also mentions the use of a centrifuge. This indicates it is a physical medical device kit, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is the preparation of platelet poor plasma and platelet concentrate from whole blood. While it states these prepared components can be used for diagnostic tests, the device itself is not performing the diagnostic test. It's a tool for preparing a sample for subsequent diagnostic use.
- Device Description: The description focuses on the physical components and the process of separating blood components by density using a centrifuge. It does not describe any components or processes that directly analyze or diagnose a condition.
- Lack of Diagnostic Function: The device's function is purely sample preparation. It doesn't measure, detect, or analyze any analytes or markers within the blood to provide diagnostic information.
Therefore, the GPS™ Platelet Separation kit falls under the category of a sample preparation device rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes
JQC
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratory or intraoperatively at point of care
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
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).
1
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:
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.
(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)
Josephine Bautista
(Division Sign-Off) Division of Clinical Laboratory Device 510(k) Number