(30 days)
No
The device description and intended use focus on a physical kit and centrifuge-based separation process, with no mention of software, algorithms, or AI/ML terms.
No.
The device is used for the preparation of blood components for diagnostic tests, not for direct therapeutic application to a patient.
No
The device is designed for the preparation of blood components (platelet poor plasma and platelet concentrate), which can then be used for diagnostic tests, but the device itself does not perform the diagnostic function.
No
The device description explicitly lists multiple physical components (needles, syringes, petri dish, etc.) that are part of the kit, indicating it is a hardware-based medical device.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that "The plasma and concentrated platelets can be used for diagnostic tests." This is a key indicator of an IVD, as the prepared components are intended for use in diagnostic procedures.
- Device Description: The device is designed to prepare blood components (platelet poor plasma and platelet concentrate) from a blood sample. While the preparation itself isn't a diagnostic test, the output is intended for use in such tests.
- Care Setting: The intended user/care setting is the "clinical laboratory or intra-operatively at point of care," which are typical environments where diagnostic testing is performed.
While the device itself doesn't perform the diagnostic test, it is a crucial component in the process of preparing the sample for diagnostic testing. This aligns with the definition of an IVD, which includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
N/A
Intended Use / Indications for Use
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.
Product codes
LXG, FMF
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
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 intra-operatively 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
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
Key Metrics
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
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
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
Intended Use:
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.
1
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 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.
(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 -