NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000

K033685 · Medical Cv, Inc. · KRH · Aug 3, 2004 · Cardiovascular

Device Facts

• Record ID: K033685
• Device Name: NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000
• Applicant: Medical Cv, Inc.
• Product Code: KRH · Cardiovascular
• Decision Date: Aug 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MedicalCV, Inc. Northrup Universal Annuloplasty System is indicated as a reinforcement for repair of the human cardiac mitral or tricuspid valves damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.

Device Story

The Northrup Universal Annuloplasty System is a flexible annuloplasty ring designed for implantation in the mitral or tricuspid position. The system includes the ring mounted on a holder assembly and a set of sizing instrumentation. Surgeons use the device to reinforce valve repair in cases of acquired or congenital disease or to replace existing rings. The ring is flexible, allowing for implantation as either a partial or complete ring based on surgeon preference and patient anatomy. The device is used in a surgical setting by cardiac surgeons. It provides structural support to the valve annulus, potentially improving valve function and patient outcomes.

Clinical Evidence

Bench testing only. Biocompatibility testing confirmed materials are non-toxic, non-hemolytic, and non-pyrogenic. Suture retention testing demonstrated adequate retention force compared to predicate devices. No clinical data provided.

Technological Characteristics

Flexible annuloplasty ring; implantable as partial or complete ring; includes holder assembly and sizing instrumentation. Materials are biocompatible (non-toxic, non-hemolytic, non-pyrogenic).

Indications for Use

Indicated for patients requiring reinforcement for repair of human cardiac mitral or tricuspid valves damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. Contraindicated if visual inspection confirms the valve is not repairable and requires replacement.

Regulatory Classification

Identification

An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”

Predicate Devices

• CarboMedics AnnuloFlex Annuloplasty System (K992056)
• Edwards Lifesciences Cosgrove-Edwards Annuloplasty System (K923367)
• Baxter Carpentier-Edwards Physio Annuloplasty Ring (K926138)

Submission Summary (Full Text)

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## Section II

## Summary of Safety and Effectiveness (as required by 21 CFR 807.92)

## Northrup Universal Annuloplasty System™

| Submitter: | MedicalCV, Inc.<br>9725 South Robert Trail<br>Inver Grove Heights, MN 55077<br>USA | | Contact: | Denny Steger<br>V.P. RA/QA<br>Phone: [phone]<br>Fax: [phone] | |
|------------------|------------------------------------------------------------------------------------|-------------------|----------------------|------------------------------------------------------------------------|--|
| Date of Summary: | | October 15, 2003 | Classification Name: | Annuloplasty Ring | |
| Common Name: | | Annuloplasty Ring | Proprietary | Northrup Universal<br>Annuloplasty SystemTM | |

The Northrup Universal Annuloplasty System consists of an Description of Device: Description of Dettoo.
annuloplasty ring mounted on a holder assembly for implantation in the mitral or tricuspid position. A complete set of instrumentation is available separately to properly size the annulus.

The MedicalCV Northrup Universal Annuloplasty System is Statement of Intended Use: Statement of Intended 050. acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.

The Northrup Universal Annuloplasty System is a flexible Technological Comparison: annuloplasty ring that can be implanted either as a partial or complete ring, according to the surgeon's preference and/or patient condition. For purposes of this submission, the Northrup Universal Annuloplasty System was compared to the following predicate device(s):

- CarboMedics AnnuloFlex Annuloplasty System K992056 .
- can be implanted either as a partial or complete ring with identical function as ﺖ the Northrup Universal Annuloplasty System
- Edwards Lifesciences Cosgrove-Edwards Annuloplasty System K923367 .
- Baxter Carpentier-Edwards Physio Annuloplasty Ring K926138 .

The results of biocompatibility testing support that the materials Testing: used in the manufacture of the Northrup Universal Annuloplasty System are non-toxic, nonhemolytic, and non-pyrogenic. All testing was conducted under Good Laboratory Practices per 21 nemoryte, and non pyrog testing for the Northrup Universal Annuloplasty System includes suture retention testing which demonstrated that the design provided for a more than adequate retention force as compared to the predicate device. Testing demonstrated that the aucquate Neemal Annuloplasty System is substantially equivalent to the predicate device for repair of the mitrial or tricuspid valve.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 3 2004

MedicalCV, Inc. c/o Mr. Denny Steger Vice President Regulatory Affairs 9725 South Robert Trial Inver Grove Heights, MN 55077

Re: K033685

Northrup Universal Annuloplasty System™ Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II (two) Product Code: KRH Dated: June 22, 2004 Received: June 24, 2004

Dear Mr. Steger:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for about in to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner to may been reclassified in accordance with the provisions of the Federal Food, Drug, de neces may nave been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The rou may) increasons 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 (PMA), it n your device to such additional controls. Existing major regulations affecting your device can may be babyer is been are decal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Denny Steger

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please 11 you ttee Office of Compliance at [phone]. Additionally, for questions on the vomotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dana R. Richner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and · Radiological Health

Enclosure

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## Indications for Use Statement

K033685 510(K) Number:

Northrup Universal Annuloplasty System™ Device Name:

Indications for Use: The MedicalCV, Inc. Northrup Universal Annuloplasty System is indicated as a reinforcement for repair of the human cardiac mitral or tricuspid valves damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.

Prescription Use X (Per 21 CFR 801.109) OR

Over-the-Counter Use

(Please do not write below this line - Continue on another page if necessary)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duana R. Vachner

(Division Sign-Off) Division of Cardiovascular. Respiratory, and Neurological Devices 510(k) Number 4033685