(140 days)
Not Found
No
The summary describes a mechanical annuloplasty ring and its accessories, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is an implantable annuloplasty ring used to reinforce or replace damaged heart valves, directly addressing and treating a medical condition.
No
Explanation: The provided text describes the Mitra-Lift as an implant for reinforcing the repair or replacing a previously implanted annuloplasty ring for cardiac valves. Its function is to be implanted into the body to assist in the repair of the mitral and tricuspid valves, not to diagnose a condition.
No
The device description explicitly states it is a "set of devices" including an "implant device" constructed of "polyester textile materials," which are physical components, 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 states that the Mitra-Lift is used for the repair or replacement of human cardiac mitral and tricuspid valves. This is a surgical intervention performed in vivo (within the living body).
- Device Description: The device is described as an implant device constructed of polyester textile materials, intended for surgical use.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, etc.) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. The Mitra-Lift is a surgical implant used to physically repair or replace heart valves.
N/A
Intended Use / Indications for Use
The Mitra-Lift is indicated as reinforcement for repair of the human cardiac mitral and 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.
The Mitra-Lift Set is indicated as reinforcement for repair of the human mitral 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
Mitra-Lift Set is set of devices for mitral annuloplasty. This set consists of Mitra-Lift (implant device for mitral annuloplasty), and its accessories (Sizers and holders). The main device (Mitra-Lift series) is supplied sterile and intended for single use only. Mitra-Lift series is constructed of polyester textile materials and provided as the various sizes. It is intended to be used with its accessories, Mitral Sizer and Holder Handle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human cardiac mitral and tricuspid valves, human mitral 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical laboratory testing was performed demonstration that the device complied with the USP Monographs and with the EP Monographs for Absorbable surgical sutures. The results of biocompatibility testing support that the materials used in the manufacture of the Mitra-Lift are non-toxic, non-hemolytic, and non-pyrogenic. All testing was conducted under Good Laboratory Practices per 21 CFR Part 58. Mechanical Integrity testing for the COMVAR Set (including Mitra-Lift Set) 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 Mitra-Lift Set is substantially equivalent to the predicate device for repair of the mitral or tricuspid valve.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
510(k) Summary
Submitter:
ScienCity Co., Ltd. Hur Eun #101,102,107,108, 3-dong, Woniu Medical Instrument Industry Park. 1720-26, Taejang-dong, Wonju-shi, Kangwon-do, 220-120, Republic of Korea Phone: 82-2-3437-0954 Fax: 82-2-3437-6888
MAY 18 2011
Official Correspondent:
Kodent Inc. Joyce Bang 325 N. Puente St. Unit B Brea, CA 92821 Email: kodentinc@gmail.com Phone: 714-525-0114 Fax: 714-525-0116
Device Information
Trade Name: Mitra-Lift Set
Device: Ring, Annuloplasty
Regulation Description: Annuloplasty Ring
Product Code: KRH
Regulation Number: 870.3800
Device Class: Class II
Submission Types: 510(K) Submission
General Description
Mitra-Lift Set is set of devices for mitral annuloplasty. This set consists of Mitra-Lift (implant device for mitral annuloplasty), and its accessories (Sizers and holders). The main device (Mitra-Lift series) is supplied sterile and intended for single use only. Mitra-Lift series is constructed of polyester textile materials and provided as the various sizes. It is intended to be used with its accessories, Mitral Sizer and Holder Handle.
Indication for Use
The Mitra-Lift is indicated as reinforcement for repair of the human cardiac mitral and 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.
Predicate Devices:
1
The subject device is substantially equivalent to the following predicate devices:
- . Simplici-T Annuloplasty System (K052970) manufactured by Medtronic Heart Valves (Medtronic).
Performance Data
Non-clinical laboratory testing was performed demonstration that the device complied with the USP Monographs and with the EP Monographs for Absorbable surgical sutures.
The results of biocompatibility testing support that the materials used in the manufacture of the Mitra-Lift are non-toxic, non-hemolytic, and non-pyrogenic. All testing was conducted under Good Laboratory Practices per 21 CFR Part 58. Mechanical Integrity testing for the COMVAR Set (including Mitra-Lift Set) 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 Mitra-Lift Set is substantially equivalent to the predicate device for repair of the mitral or tricuspid valve.
Comparison to Predicate Devices
Testing and other comparisons have established that the subject of Mitra-Lift Set is substantially equivalent in design, materials, indications and intended use, packaging, and performance to other predicate devices of the type currently marketed in the U.S.
Conclusion
The Mitra-Lift, subject of this submission, constitutes a safe, reliable and effective medical device, meeting all the declared requirements of its intended use. Device presents no adverse health effects or safety risks to patients when used as intended. The Mitra-Lift has the same intended use and fundamental scientific technology as its predicate devices Simplici-T Annuloplasty System (K052970) manufactured by Medtronic Heart Valves (Medtronic). Therefore, Mitra-Lift and its predicate devices are believed to be substantially equivalent.
2
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 8 2011
Sciencity Co.,Ltd. c/o Ms. Joyce Bang Kodent, Inc. 325 N. Puente St. Unit B Brea, California 92821
Re: K103812
Mitra-Lift Set Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II (two) Product Code: KRH Dated: May 9, 2011 Received: May 12, 2011
Dear Ms. Bang:
This letter corrects our substantially equivalent letter of May 18, 2011.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Joyce Bang
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Sciencity Co., Ltd.
Indication for Use
| 510(K) Number (if known): | K103812 |
|---|---|
| --------------------------- | --------- |
Device Name: Mitra-Lift Set
Indication for Use:
:
The Mitra-Lift Set is indicated as reinforcement for repair of the human mitral 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 _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter
(Part 21 CFR 801 Subpart D)
(Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K103812 |