(235 days)
No
The device description and intended use describe a mechanical tool for rotating a heart valve, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used to assist in the proper placement of a prosthetic heart valve, not to treat a disease or condition itself.
No
The device is described as a tool for rotating a prosthetic heart valve during implantation to avoid anatomical obstruction, which is a surgical manipulation, not a diagnostic act. Its function is to orient the valve, not to detect, diagnose, or monitor a medical condition.
No
The device description clearly describes a physical, sterile, single-use instrument made from polyetherimide, intended for manual manipulation during surgery. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to rotate a prosthetic heart valve in situ (within the body) during surgery. This is a surgical instrument used directly on a patient.
- Device Description: The description details a physical tool made of polyetherimide, designed for mechanical manipulation of a valve.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the body (like blood, urine, tissue), detecting substances, or providing diagnostic information based on in vitro 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 sterile, single use Sulzer Carbomedics Low Profile Mitral Rotator is intended for use in rotating the CarboMedics® Prosthetic Heart Valve (CPHV™) mitral valve in situ when necessary to avoid anatomical obstruction.
Product codes
MOP
Device Description
The Sulzer Carbomedics Low Profile Mitral Rotator design includes a socket that the bendable is inserted into and locked in place. This allows the surgeon to orient the valve into the position of greatest advantage for each patient. The Low Profile Mitral Rotator with the corresponding CPHV size on the rotator. The Low Profile Mitral Rotator will be made available in sizes corresponding with previously approved CPHV™ sizes. The Low Profile Valve Rotators are intended for use with the CPHV™ Mitral 700 valve series.
The Sulzer Carbomedics Low Profile Mitral Rotator will be manufactured from polyetherimide previously used with instrumentation approved with the CPHV". Polyetherimide has a history of use in medical device applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mitral valve
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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
The Sulzer Carbomedics Low Profile Mitral Rotator has been tested and compared to the predicate device, the Sulzer Carbomedics Extended Mitral Rotator (K951368, June 20, 1995). The results indicate that the Sulzer Carbomedics Low Profile Mitral Rotator is substantially equivalent to the Sulzer Carbomedics Extended Mitral Rotator.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
EDICA
Sulzer Carbomedics Inc.
1300 East Anderson Lane Austin, Texas 78752-1793
Phone (512) 435-3200 FAX (512) 435-3350 WATS (800) 648-1579 (US and Canada)
510(k) SUMMARY SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR
The sterile, single use Sulzer Carbomedics Low Profile Mitral Rotator is intended for use in rotating the CarboMedics® Prosthetic Heart Valve (CPHV™) mitral valve in situ when necessary to avoid anatomical obstruction.
The Sulzer Carbomedics Low Profile Mitral Rotator design includes a socket that the bendable is inserted into and locked in place. This allows the surgeon to orient the valve into the position of greatest advantage for each patient. The Low Profile Mitral Rotator with the corresponding CPHV size on the rotator. The Low Profile Mitral Rotator will be made available in sizes corresponding with previously approved CPHV™ sizes. The Low Profile Valve Rotators are intended for use with the CPHV™ Mitral 700 valve series.
The Sulzer Carbomedics Low Profile Mitral Rotator will be manufactured from polyetherimide previously used with instrumentation approved with the CPHV". Polyetherimide has a history of use in medical device applications. The Sulzer Carbomedics Low Profile Mitral Rotator has been tested and compared to the predicate device, the Sulzer Carbomedics Extended Mitral Rotator (K951368, June 20, 1995). The results indicate that the Sulzer Carbomedics Low Profile Mitral Rotator is substanially equivalent to the Sulzer Carbomedics Extended Mitral Rotator.
| Common name of the Device: | Valve Rotator |
|---|---|
| Trade name of Proprietary Name: | Sulzer Carbomedics Low Profile Mitral Rotator |
| Submitter and Contact Person: | Edward E. Newton |
| Sr. Regulatory Affairs Specialist | |
| 1300 E. Anderson Lane | |
| Austin, Texas 78752 | |
| Phone: (512) 435-3407 | |
| Fax: (512) 435-3351 | |
| Submission Submitted on: | June 29, 1998 |
1
Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and is centered horizontally. The words are all capitalized and evenly spaced.
Image /page/1/Picture/1 description: The image shows the words "HUMAN SERVI" in a bold, sans-serif font. The text appears to be part of a larger phrase or title, but only these two words are visible in the image. The letters are black against a white background.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 4 1998
Mr. Edward E. Newton Sr. Regulatory Affairs Specialist Sulzer Carbomedics, Inc. 1300 East Anderson Lane Austin, TX 78752-1793
Re: K974648 Sulzer Carbomedics Low Profile Mitral Rotator Regulatory Class: unclassified Product Code: MOP Dated: June 29, 1998 Received: June 30, 1998
Dear Mr. Newton:
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, qood 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 A substantially equivalent determination assumes compliance to 895. 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 requlation 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.
2
Page 2 - Mr. Edward E. Newton
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
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT
| 510(K) Number (if known): | Unknown |
|---|---|
| Device Name: | Sulzer Carbomedics Low Profile Mitral Rotator |
| Indications for Use: | The Sulzer Carbomedics Low Profile Mitral Rotator is |
| intended for use in rotating the CPHV™ mitral valve in | |
| situ when necessary to avoid anatomical obstruction. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bee & Lempersle
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K974648
Prescription Use X
OR
Over-the-Counter Use
(Optional Format 1-2-96)