← Product Code [MOP](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/MOP) · K980016

# MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE (K980016)

_Genzyme Surgical Product (Genzyme Biosurgery) · MOP · Aug 7, 1998 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/MOP/K980016

## Device Facts

- **Applicant:** Genzyme Surgical Product (Genzyme Biosurgery)
- **Product Code:** [MOP](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/MOP.md)
- **Decision Date:** Aug 7, 1998
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.3935
- **Device Class:** Class 1
- **Review Panel:** Cardiovascular

## Indications for Use

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 Story

Manual surgical instrument; consists of handle, flexible shaft, and tip. Used in open and minimally invasive cardiac valve surgeries by surgeons. Features two knobs: proximal knob adjusts tip angle (0-90 degrees) via cable tension; distal knob rotates tip (0-360 degrees). Facilitates precise positioning of Sulzer Carbomedics Low Profile Mitral Valve Sizer and Rotator during valve repair or replacement. Reusable; steam sterilized.

## Clinical Evidence

No clinical data; bench testing only.

## Technological Characteristics

Materials: ASTM surgical stainless steel and aluminum. Manual mechanical actuation via cable-driven tip control. Dimensions: handle with flexible shaft and tip. Sterilization: steam. Reusable.

## Regulatory Identification

A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place.

## Predicate Devices

- Diamond Touch and Micro Diamond Touch/Diamond Line Instruments ([K960400](/device/K960400.md))
- Carbomedics Extended Mitral Rotator ([K951368](/device/K951368.md))
- Carbomedics Handle ([K962154](/device/K962154.md))

## Submission Summary (Full Text)

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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
- 2. 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

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.

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K980016
Page 2 of 2

## 5. INDICATIONS FOR USE

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.

# 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 Valve<br>Introducer/Rotator<br>Handle<br>(proposed) | Diamond Touch<br>and<br>Micro Diamond Touch<br>(K960400) | Carbomedics Extended<br>Mitral Rotator<br>(K951368)<br>Carbomedics Handle<br>(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:

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.

(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)

OR

Over-The-Counter Use _

(Optional Format 1-2-96)

---

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