The 3i "CelSep" Centrifuge System, 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 (50-60ml) of whole blood.

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

Device Description

"CelSep" Centrifuge System consists of a table-top, non self-decanting, swinging bucket centrifuge and single-use processing disposable, designed to permit rapid and completely self-contained and safe separation of plasma and platelets from a small volume of whole blood. The centrifuge spins at a maximum speed of 3400 rpms at a maximum force of approximately 2050g.

AI/ML Overview

The provided text is a 510(k) summary for the 3i CelSep Centrifuge System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the way a medical device seeking de novo authorization or a clinical trial report would.

Therefore, many of the requested sections (2-9) cannot be fully answered as the provided document does not contain that level of detail regarding a formal study to prove performance against acceptance criteria. The submission is a comparison of technological characteristics to a legally marketed predicate device.

Here's an attempt to extract and interpret the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of performance thresholds for a new device. Instead, the submission focuses on demonstrating substantial equivalence to an existing predicate device based on technological characteristics. The "performance" is implied by demonstrating that its characteristics are similar enough to the predicate to perform the intended function safely and effectively.

Feature / Characteristic	Predicate Centrifuge (Reference)	3i "CelSep" (Proposed Device)	Substantial Equivalence Justification / Performance
Principle of operation	Separation based on density processing speed and equipment	Separation based on density processing speed and equipment	Equivalent
Table-Top Design	Yes	Yes	Equivalent
Refrigerated	No	No	Equivalent
Swinging Bucket	Yes	Yes	Equivalent
Automatic Decanting	Yes	No (1)	Difference noted: Justified as not required by "CelSep" design (manual, pneumatic decanting with self-contained disposable).
Micro-Processor Controlled	Yes	Yes	Equivalent
User Programmable	No	Yes	Difference noted: This is an added feature, not a detraction from equivalence.
Speed Control	Preset	Selectable	Difference noted: Selectable speed control offers more flexibility.
Maximum RPM	6000g (likely a typo, should be RPM)	3400 RPM	Difference noted: Lower max RPM, but "CelSep" requires lower speeds.
Maximum RCF	3550g	2050 RPM (likely a typo, should be g)	Difference noted: Lower max RCF, but "CelSep" requires lower speeds.
Processing capacity	2 disposables 50ml/disposable	1 disposable 60ml/disposable	Difference noted: Different capacity, but both capable of processing small blood samples.
Lid Locking/Holding	Yes	Yes	Equivalent
Imbalance Detector	Yes	No (2)	Difference noted: Justified as not required due to lower speeds.
Construction	Anti-rotational, metal housing and rotor	Anti-rotational, metal housing and rotor	Equivalent

Note: The performance of the device in terms of preparing platelet poor plasma and platelet concentrate from a small sample of blood is stated as its intended use. The 510(k) process typically relies on demonstrating that the device performs as well as or in a similar manner to the predicate device for its intended use, rather than requiring new, specific performance metrics studies like accuracy, sensitivity, or specificity. The "acceptance criteria" here are essentially the shared technological characteristics with the predicate device, implying that if the characteristics are substantially equivalent, the performance for the intended use will also be equivalent.

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

The provided document does not describe a formal test set, sample size, or data provenance from a prospective or retrospective study to evaluate the device's performance against specific metrics. The submission focuses on comparing the device's technological characteristics to a predicate device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not available in the provided 510(k) summary. The submission does not detail a study where ground truth was independently established by experts for a test set.

4. Adjudication Method

This information is not available in the provided 510(k) summary. There is no mention of an adjudication process for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not reported in this 510(k) summary. This type of study is typically associated with AI/CAD devices that assist human readers in interpretation, which is not the function of a centrifuge.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

This question is not applicable. The 3i CelSep Centrifuge System is a physical device, not an algorithm, and therefore doesn't have "standalone" algorithm performance in the context of AI/CAD devices. Its operation is independent of human interpretation of algorithmic output.

7. The Type of Ground Truth Used

This information is not available in the provided 510(k) summary. The summary does not describe a study that required establishing 'ground truth' in the context of clinical outcomes, pathology, or expert consensus. The equivalence is based on device characteristics and intended use.

8. The Sample Size for the Training Set

This information is not available in the provided 510(k) summary. The device is a centrifuge, not an AI model requiring a training set.

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

This information is not available in the provided 510(k) summary. The device is a centrifuge, not an AI model requiring a training set and associated ground truth establishment.

Summary

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K994148

510(k) SUMMARY 3i CelSep Centrifuge System

Submitter's name and address:	Implant Innovations, Inc.4555 Riverside DrivePalm Beach Gardens, FL 33410
Telephone:	(561) 776-6819
Contact Person:	William G. Conety
Date Summary prepared:	1999 November 02
Device proprietary/trade name:	"CelSep" Centrifuge System
Common name:	General Purpose Centrifuge for Clinical Use
Classification Name:	General purpose laboratory equipment labeled orpromoted for a specific medical use (21 CFR862.2050)
Substantial Equivalence:	The proposed device is substantially equivalent toother table-top centrifuges previously cleared by theFDA via the 510(k) Notification process.
Device Description:	"CelSep" Centrifuge System consists of a table-top,non self-decanting, swinging bucket centrifuge andsingle-use processing disposable, designed to permitrapid and completely self-contained and safeseparation of plasma and platelets from a smallvolume of whole blood. The centrifuge spins at amaximum speed of 3400 rpms at a maximum forceof approximately 2050g.
Intended Use:	The 3i "CelSep" centrifuge System is designed foruse in the clinical laboratory or intraoperatively atpoint-of-care for the safe and rapid preparation ofplatelet poor plasma and platelet concentrate from asmall sample of blood.
Technological Characteristics:	"CelSep" centrifuge has the same technologicalcharacteristics and is similar in design andconfiguration compared with the predicate device(See Table 15c)
Principle of operation	Separation based on densityprocessing speed and equipment	Separation based on densityprocessing speed and equipment
Table-Top Design	Yes	Yes
Refrigerated	No	No
Swinging Bucket	Yes	Yes
Automatic Decanting	No (1)	Yes
Micro-Processor Controlled	Yes	Yes
User Programmable	Yes	No
Speed Control	Selectable	Preset
Acceleration/breaking	Current-controlled	Current-controlled
Maximum RPM	3400 RPM	6000g
Maximum RCF	2050 RPM	3550g
Processing capacity	1 disposable60ml/disposable	2 disposables50ml/disposable
Lid Locking/Holding	Yes	Yes
Imbalance Detector	No (2)	Yes
Construction	Anti-rotational, metalhousing and rotor	Anti-rotational, metalhousing and rotor

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Table 15a

COMPARISON OF 3i "CelSep" AND PREDICATE CENTRIFUGE

Features

3i "CelSep"

Predicate Centrifuge

(1) The "CelSep" centrifuge is not automatic decanting by design. The processing disposable is completely self-contained and is manually, pneumatically decanting.
(2) No imbalance detection feature is required by "CelSep" due in part to the lower speeds required for processing.

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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 features a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

1 2000 FEB

Mr. William G. Conety Regulatory Affairs Implant Innovations, Inc. 4555 Riverside Drive Palm Beach Gardens, Florida 33410

Re: K994148

Trade Name: 3i "CelSep" Centrifuge System Regulatory Class: I Product Code: JQC Dated: December 1, 1999 Received: December 8, 1999

Dear Mr. Conety:

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 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. 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.

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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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 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,

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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510(k) Number: K 994/48

Page 1 of 1

3i "CelSep" Centrifuge System Device Name:

INDICATIONS FOR USE:

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

DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rita E. Madini

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K994148

Prescription Use: √
(Per 21 CFR 801.109)

Over the counter use: ________________________________________________________________________________________________________________________________________________________

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.