(253 days)
Not Found
No
The 510(k) summary describes a physical medical device (an annuloplasty ring) and its associated instrumentation. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven decision-making components. The performance studies focus on biocompatibility and mechanical properties, not algorithmic performance.
Yes
The device is indicated for the repair of human cardiac mitral or tricuspid valves damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring, which is a therapeutic intervention.
No
Explanation: The device is described as an annuloplasty system for repairing heart valves, acting as a reinforcement or replacement. Its function is interventional/therapeutic, not diagnostic.
No
The device description clearly states it consists of an annuloplasty ring mounted on a holder assembly, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Northrup Universal Annuloplasty System is a physical device (an annuloplasty ring) intended for surgical implantation to repair damaged heart valves. It is a medical device used in vivo (within the living body), not a test performed in vitro (in a lab setting).
The information provided focuses on the device's physical characteristics, surgical application, biocompatibility, and mechanical performance, all of which are typical for an implantable medical device, not an IVD.
N/A
Intended Use / 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.
Product codes
KRH
Device Description
The Northrup Universal Annuloplasty System consists of an 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human cardiac mitral or tricuspid valves
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
The results of biocompatibility testing support that the materials 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.3800 Annuloplasty ring.
(a)
Identification. An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”
0
Section II
Summary of Safety and Effectiveness (as required by 21 CFR 807.92)
Northrup Universal Annuloplasty System™
| Submitter: | MedicalCV, Inc.
9725 South Robert Trail
Inver Grove Heights, MN 55077
USA | | Contact: | Denny Steger
V.P. RA/QA
Phone: 651 452 3000
Fax: 651 452 4948 | |
|------------------|------------------------------------------------------------------------------------|-------------------|----------------------|------------------------------------------------------------------------|--|
| Date of Summary: | | October 15, 2003 | Classification Name: | Annuloplasty Ring | |
| Common Name: | | Annuloplasty Ring | Proprietary | Northrup Universal
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.
1
Image /page/1/Picture/2 description: The image shows a circular emblem. The emblem features a stylized depiction of an eagle's head and neck, composed of three parallel, curved lines. The emblem is encircled by text that reads "U.S. HEALTH & HUMAN SERVICES - USA".
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.
2
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 (301) 594-4646. Additionally, for questions on the vomotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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Page 1 of 1
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