(217 days)
Not Found
No
The device description and intended use describe a purely mechanical instrument for surgical manipulation, with no mention of computational or data-driven features.
No
The device is described as an instrument used for surgical introduction and rotation of a valve sizer and rotator during cardiac valve surgeries, indicating it is a surgical tool rather than a device intended to treat or prevent a disease or condition.
No.
The device is described as an instrument for surgical introduction and rotation of a valve sizer and rotator during cardiac valve surgeries. Its function is to manipulate and position other surgical tools, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly outlines physical components (handle, flexible shaft, tip, knobs) and their mechanical functions, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "surgical introduction and rotation of a Sulzer Carbomedics Low Profile Mitral Valve Sizer and Rotator" during "open and minimally invasive cardiac valve surgeries." This describes a surgical instrument used in vivo (within the body) during a procedure.
- Device Description: The description details a mechanical instrument with a handle, shaft, and tip for manipulating another surgical tool. This is consistent with a surgical instrument, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.), detect markers, or provide diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MOP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cardiac valve
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
-
- 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.
1
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
Introducer/Rotator
Handle
(proposed) | Diamond Touch
and
Micro Diamond Touch
(K960400) | Carbomedics Extended
Mitral 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
2
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.
3
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
4
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)