The Genzyme Surgical Products Millennium Valve Introducer/Rotator Handle is indicated for use during open and minimally invasive cardiac valve surgeries. This instrument is indicated for surgical introduction and rotation of a Sulzer Carbomedics Low Profile Mitral Valve Sizer and Rotator.

Device Description

The Millennium Valve Introducer/Rotator Handle (Introducer/Rotator Handle) consists of a handle, flexible shaft, and tip. The Handle includes two knobs that control the orientation and position of the tip. The proximal knob tightens the cable that adjusts the tip between 0 and 90 degrees. The distal knob rotates the tip between 0 and 360 degrees.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Genzyme Surgical Products Millennium Valve Introducer/Rotator Handle. This type of submission is a regulatory pathway for medical devices that are substantially equivalent to a legally marketed predicate device. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical trial or performance study for a diagnostic algorithm would.

The document primarily focuses on establishing "substantial equivalence" based on operational and technological characteristics. Therefore, many of the requested categories are not applicable to this type of regulatory submission.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as performance metrics with thresholds (e.g., accuracy > 90%). The "acceptance criteria" for a 510(k) submission like this are essentially demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and safety/effectiveness.
Reported Device Performance: The document provides a comparison of characteristics between the proposed device and predicate devices. This isn't "performance" in the statistical sense, but rather a functional comparison.

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (Proposed Device)
Indicated for minimally invasive cardiovascular surgery	Must be "Yes" to be equivalent to K960400	Yes
Indicated for valve repair/replacement	Must be "Yes" to be equivalent to K951368/K962154	Yes
Materials: ASTM Surgical Stain steel and Aluminum	Must be "Yes" to be equivalent to K960400	Yes
Sterility Status: Reusable	Must be "Yes" to be equivalent to predicate devices	Yes
Sterilization Process	Must be "Steam" to be equivalent to predicate devices	Steam
Intended Use	Must be equivalent or nearly equivalent to predicate devices	Indicated for surgical introduction and rotation of a Sulzer Carbomedics Low Profile Mitral Valve Sizer and Rotator. (Matches predicate devices' function)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable to this 510(k) submission. There is no "test set" in the context of evaluating a diagnostic algorithm's performance. The submission relies on comparative analysis with predicate devices and descriptive information.

3. 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)

This information is not applicable. There is no "ground truth" establishment in the context of a performance study for this type of mechanical surgical instrument.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable.

5. 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

This information is not applicable. This device is a surgical instrument, not an AI or diagnostic tool designed to assist human readers.

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

This information is not applicable. This device is a surgical instrument, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not applicable.

8. The sample size for the training set

This information is not applicable. There is no "training set" for this type of mechanical surgical instrument.

9. How the ground truth for the training set was established

This information is not applicable.

Summary

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K 980016
page 1 of 2

AUG - 7 1998

510(k) Summary Genzyme Surgical Products Millennium Valve Introducer/Rotator Handle (per 21 CFR 807.92)

1. SUBMITTER NAME AND ADDRESS

Genzyme Surgical Products 5175 South Royal Atlanta Drive Tucker, GA 30084

Contact Person:	Michelle M. Johnston
	Telephone: 770-496-0952

Date Prepared: March 23, 1998
1. DEVICE NAME

Proprietary Name:	Millennium Valve Introducer/Rotator Handle
Common/Usual Name:	Introducer/Rotator Handle
Classification Name:	Accessory to Valve Holder or Valve

3. PREDICATE DEVICE

Diamond Touch and Micro Diamond Touch/Diamond Line Instruments K960400

Carbomedics Extended Mitral Rotator K951368

Carbomedics Handle K962154

4. DEVICE DESCRIPTION

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K980016
Page 2 of 2

5. INDICATIONS FOR USE

BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

Operational and technological characteristics form the basis for the determination of substantial equivalence of the proposed Introducer/Rotator Handle and the predicate devices. Information provided in this 510(k) premarket notification includes descriptive information about the intended use, operation, and technological characteristics. A side-by-side comparison of the two instrument systems is provided in the table below.

Characteristic	Millennium ValveIntroducer/RotatorHandle(proposed)	Diamond TouchandMicro Diamond Touch(K960400)	Carbomedics ExtendedMitral Rotator(K951368)Carbomedics Handle(K962154)
Indicated for minimally invasive cardiovascular surgery	Yes	Yes	Unknown
Indicated for valve repair/replacement	Yes	No	Yes
Indicated for valve repair/replacement	Yes	No	Yes
Materials: ASTM Surgical Stain steel and Aluminum	Yes	Yes	Unknown
Sterility Status: Reusable	Yes	Yes	Yes
Sterilization Process	Steam	Steam	Steam

Comparison of the Millennium Valve Introducer/Rotator Handle and Predicate Devices

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an eagle-like emblem with three stylized human profiles facing right, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircles the emblem, indicating the department's name and national affiliation.

AUG - 7 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Genzyme Surqical Products c/o Ms. Rosina Robinson Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re: K980016 Millennium Valve Introducer/Rotator Handle Regulatory Class: unclassified Product Code: MOP Dated: March 24, 1998 Received: March 25, 1998

Dear Ms. Robinson:

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 Requlations, 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 requlations.

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Page 2 - Ms. Rosina Robinson

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), promotion , or advertising, 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,

Thomas J. Callahan, Ph.D.

Thomas J. Call Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510(k) Number (if known): K980016

Device Name: Genzyme Surgical Products Millennium Valve Introducer/Rotator Handle

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

Betee L. Camperele

(Division Sign-Off) (Division Sign-Oit)
Division of Cardiovascular, Respiratory, and Neurological Devices and Nouronog

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use _

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.3935 Prosthetic heart valve holder.

(a)
Identification. A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place.(b)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.