(77 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical annuloplasty ring, with no mention of AI/ML technologies.
Yes.
The device is indicated for use to correct annular dilation and prevent further dilatation of the mitral valve annulus caused by diseased states, which is a therapeutic purpose.
No
The device is an annuloplasty ring used to correct annular dilation of the mitral valve, not to diagnose a condition. It is a treatment device.
No
The device description explicitly states it is a "rigid core machined from titanium covered with a double velour polyester fabric" and is "mounted on a holder," indicating it is a physical implantable device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (inside the body) to physically repair and support the mitral valve annulus. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device is a physical implantable ring made of titanium and polyester fabric, designed to be surgically placed. This is consistent with an implantable medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with IVD devices.
Therefore, the SJM™ Rigid Saddle ring is an implantable medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SJM™ Rigid Saddle Ring is indicated for use to correct annular dilation, increase leaflet coaptation, and prevent further dilatation of the mitral valve annulus caused by liseased states such as degenerative disease, rheumatic disease, ischemia or vascular disease. The combination of prosthetic ring with valvuloplasty may be used in all acquired or congenital mitral insufficiencies with dilation and deformation of the fibrous mitral annulus.
For mitral insufficiencies with no subvalvular lesions and normal valvular movements, r of that ring implant alone may be sufficient. However, annuloplasty ring implant along with mitral valvuloplasty repair must be considered for insufficiencies with a prolapsed while mark relongation or rupture of the chordae tendineae and for insufficiencies with valve ado to blongation ements due to fusion of the commissures or chordae tendineae, or chordal hypertrophy.
Product codes (comma separated list FDA assigned to the subject device)
KRH
Device Description
The SJM™ Rigid Saddle Ring assembly consists of a rigid core machined from titanium covered with a double velour polyester fabric with a sewing cuff created for suturability. The ring is mounted on a holder and placed in a dual barrier package system. The package system is then steam sterilized. The SJM™ Rigid Saddle Ring is available in sizes 24mm-34mm (even sizes). Sizing is based on the inter-commissural distance as indicated by the commissure markers placed on the ring.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mitral valve annulus
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)
The following performance testing was conducted;
- Ring Tensile Strength .
- Ring compressive Strength .
- Suture Pullout Test .
- Needle Penetration Test .
- Computational Structural Analysis
- Holder Evaluation .
- Assembled Ring/Holder Evaluation .
- MR Safety .
- Package Shelf Life Evaluation .
- Manufacturing Process validation .
- Biocompatibility Evaluation .
- Chemical and Morphological Evaluation .
- Sterilization Validation .
- Bioburden .
- Pyrogenicity .
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.
K032250-Edwards Lifesciences GeoForm™ annuloplasty ring model 4200 (Carpentier-McCarthy-Adams |MR-ETlogix annuloplasty ring model 4100)
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
§ 870.3800 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
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510(K) SUMMARY
(as required by 21 CFR 807.92)
Submitters Information A.
| Submitter's Name and Address: | St. Jude Medical, Inc.
Cardiac Surgery Division
One Lillehei Plaza
St. Paul, MN 55117 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name | William McKelvey, RAC
Regulatory Affairs Specialist
St. Jude Medical, Inc.
Bus: (651) 415-7029
Fax: (651) 766-3049
Email: wmckelvey@sjm.com |
| Submission Prepared | September 30, 2004 |
B. Device Information
| Proprietary Name: | SJM™ Rigid Saddle ring
model RSAR-(size) |
| ------------------- | --------------------------------------------- |
|---|
Common or Usual Name:
Classification:
Predicate Device:
K032250-Edwards Lifesciences GeoForm™ annuloplasty ring model 4200 (Carpentier-McCarthy-Adams |MR-ETlogix annuloplasty ring model 4100)
Rigid Annuloplasty ring,
Class II per 21 CFR 870.3800,
Mitral Repair Ring
Annuloplasty rings
Device Description:
The SJM™ Rigid Saddle Ring assembly consists of a rigid core machined from titanium covered with a double velour polyester fabric with a sewing cuff created for suturability. The ring is mounted on a holder and placed in a dual barrier package system. The package system is then steam sterilized. The SJM™ Rigid Saddle Ring is available in sizes 24mm-34mm (even sizes). Sizing is based on the inter-commissural distance as indicated by the commissure markers placed on the ring.
SJM® IAR annuloplasty ring - 510(k) Summary
01
1
Intended Use:
The SJM™ Rigid Saddle Ring is indicated for use to correct annular dilation, increase leaflet coaptation, and prevent further dilatation of the mitral valve annulus caused by liseased states such as degenerative disease, rheumatic disease, ischemia or vascular disease. The combination of prosthetic ring with valvuloplasty may be used in all acquired or congenital mitral insufficiencies with dilation and deformation of the fibrous mitral annulus.
For mitral insufficiencies with no subvalvular lesions and normal valvular movements, r of that ring implant alone may be sufficient. However, annuloplasty ring implant along with mitral valvuloplasty repair must be considered for insufficiencies with a prolapsed while mark relongation or rupture of the chordae tendineae and for insufficiencies with valve ado to blongation ements due to fusion of the commissures or chordae tendineae, or chordal hypertrophy.
Comparison of Required Technological Characteristics C.
SJM considers the SJM™ Rigid Saddle Ring to be substantially equivalent in technological characteristics (e.g. design and materials) and intended use to the predicate devices. The table below is a comparison of the equivalency characteristics between the SJM™ Rigid Saddle Ring and the predicate device.
| Characteristic | Equivalency |
|---|---|
| a. Product Labeling | Substantially Equivalent |
| b. Intended Use | Substantially Equivalent |
| c. Physical Characteristics | Substantially Equivalent |
| d. Anatomical Sites | Identical |
| e. Target Population | Substantially Equivalent |
| f. Performance Testing | Substantially Equivalent |
| g. Safety Characteristics | Substantially Equivalent |
Summary of Non-Clinical Tests D.
The following performance testing was conducted;
- Ring Tensile Strength .
- Ring compressive Strength .
- Suture Pullout Test .
- Needle Penetration Test .
SJM® IAR annuloplasty ring ~ 510(k) Summary
2
- Computational Structural Analysis
- Holder Evaluation .
- Assembled Ring/Holder Evaluation .
- MR Safety .
- Package Shelf Life Evaluation .
- Manufacturing Process validation .
- Biocompatibility Evaluation .
- Chemical and Morphological Evaluation .
- Sterilization Validation .
- Bioburden .
- Pyrogenicity .
Conclusion
SJM has demonstrated that the SJM™ Rigid Saddle Ring is safe and effective for the intended use. The SJM™ Rigid Saddle Ring is, with respect to intended use and technological characteristics, substantially equivalent to the predicate device.
SJM® IAR annuloplasty ring - 510(k) Summary
3
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 2004
St. Jude Medical, Inc. c/o Mr. William McKelvey Regulatory Affairs Specialist Cardiac Surgery Division One Lillehei Plaza St. Paul, MN 55117
K042734 Re:
SJMTM Rigid Saddle Ring Model RSAR-(size) Regulation Number: 21 CFR 870.3800 Regulation Name: Rigid Annuloplasty Ring Regulatory Class: Class II (two) Product Code: KRH Dated: September 30, 2004 Received: October 1, 2004
Dear Mr. McKelvey:
We have reviewed your Section 510(k) premarket notification of intent to market the device in diedi we nave reviewed your becaon 910(t) promotion is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in intersuate for tose stated in the clebosity to regally manation to the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Ford, Frys commerce prior to May 20, 1976, are encordance with the provisions of the Federal Food, Drug, devices that have been recuired in accession in accessor and of a premarket approval application (PMA). and Cosment Act (Act) that do not require approvial controls provisions of the Act. The You may, uteretore, market me device, books of the months for annual registration, listing of general controls provisions of the rest 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 If your device is classified (500 a00 v) ols. Existing major regulations affecting your device can may be subject to such additional controliations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Mr. William McKelvey
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 or any I vith 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 OFF Part 877) its extens (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. product radiall of own 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 promation hotel in "Tresults 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 contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion 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 (2017) 97 + 1055 - 1055 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,
Duma R. Lechner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
U.S. Food and Drug Administration - Center for Devices and Radiological Health
Page 1 of 1 -
510(k) Number (if known): K042734
SJM™ Rigid Saddle Ring _______________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use
The SJM™ Rigid Saddle ring is indicated for use to correct annular dilation, increase The Ouw - Right Cadele Heather dilatation of the mitral valve annulus caused by diseased states such as degenerative disease, rheumatic disease, Ischemia or vascular disease. The combination of prosthetic ring with valvuloplasty may be used in all discuse. "The ochibitation insufficiencies with dilation and deformation of the fibrous mitral annulus.
For mitral insufficiencies with no subvalvular lesions and normal valvular movements, r of thirds including may be sufficient. However, annuloplasty ring implant prostred img million valvuloplasty repair must be considered for insufficiencies with a along with intral value of elongation or rupture of the chordae tendineae and for insufficiencies with limitation of valvular movements due to fusion of the commisures or chordae tendineae, or chordal hypertrophy.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dwane D. Schurch
(Division Sign-Off) (Division Orgin Sign Scular Devices
510(k) Number_K642734