(192 days)
K970119, NDA#18-331
Not Found
No
The summary describes a mechanical surgical device for meniscal repair and does not mention any software, image processing, or AI/ML terms.
No.
The device is used for arthroscopic fixation of meniscus lesions, which is a surgical repair, not a therapeutic treatment.
No
The device is described as a "Meniscal Repair System" intended for "arthroscopic fixation of longitudinal vertical meniscus lesions." It is a surgical tool used for treatment, not for diagnosis.
No
The device description explicitly states it is a "sterile, two I router Description: 'Ho witting of a molded PLA Backstop and Tophat'," 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 the device is for the "arthroscopic fixation of longitudinal vertical meniscus lesions". This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details a "molded PLA Backstop and Tophat", which are physical components used in a surgical repair.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body. This device is a surgical tool used within the body for repair.
N/A
Intended Use / Indications for Use
The Mitek RapidLoc™ Meniscal Repair System is intended for use in the arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (red-red and red-white zones).
Product codes (comma separated list FDA assigned to the subject device)
87 MAI, MAI, GAS and GAM
Device Description
The Mitek RapidLoc™ Meniscal Repair System described in this 510(k) is a sterile, two I router Description: "Ho witting of a molded PLA Backstop and Tophat.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
meniscus
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)
Safety and Performance data has been provided to support subtantial equivalence of the Mitek RapidLoc TM Meniscal Repair System:
Performance Testing:
- ormance Testing.
Strength comparison (RapidLoc™ Meniscal Repair System vs. Mitek "H" Fix) . - Sucurem Compurison (RapidLoc™ Meniscal Repair System vs. PDS Suture) ●
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.
K970119, NDA#18-331
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K02406
FEB 1 5 2001
510(k) Summary
| Trade Name: | Mitek RapidLoc™ Meniscal Repair System |
|---|---|
| Sponsor: | Mitek Products |
| 249 Vanderbilt Avenue | |
| Norwood, MA 02062 | |
| Registration #1221934 | |
| Contact: | Christine Kuntz-Nassif |
| Sr. Regulatory Affairs Associate | |
| Telephone: (781) 251-2974 | |
| Fax: (781) 278-9578 | |
| Device Generic Name: | Fastener Fixation, Biodegradable, Soft Tissue |
| Classification: | According to Section 513 of the Federal Food, Drug, and |
| Cosmetic Act, the device classification is Class II. | |
| Product Code: | 87 MAI |
| Predicate Devices: | K970119 - Mitek "H" Fix; NDA#18-331 - PDS Absorbable Suture |
Product Description: The Mitek RapidLoc™ Meniscal Repair System described in this 510(k) is a sterile, two I router Description: "Ho witting of a molded PLA Backstop and Tophat.
Indications for Use:
The RapidLoc™ Meniscal Repair System is intended for use in the arthroscopic fixation of longitudinal wertical meniscus lesions (bucket-handle lesions) located in the vasularized area of the meniscus (red-red and red-white zones).
Safety and Performance:
Safety and Performance data has been provided to support subtantial equivalence of the Mitek RapidLoc TM Meniscal Repair System:
Performance Testing:
- ormance Testing.
Strength comparison (RapidLoc™ Meniscal Repair System vs. Mitek "H" Fix) . - Sucurem Compurison (RapidLoc™ Meniscal Repair System vs. PDS Suture) ●
Conclusion:
Conclusion:
Based on 1) safety and performance data, and 2) similarities in design, operating principle, biocompatibility and Based on 1) safety and periornalice uala, and 27 simminted in dosign opening production in the substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 5 2001
Ms. Christine Kuntz-Nassif Senior Regulatory Affairs Associate Mitek Products 249 Vanderbilt Avenue Norwood, Massachusetts 02062
Re: K002406
Trade Name: Rapidloc™Meniscal Repair System Regulatory Class: II Product Code: MAI, GAS and GAM Dated: November 16, 2000 Received: November 17, 2000
Dear Ms. Kuntz-Nassif:
We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your Security from hoursentially equivalent (for the indications for use above and we nave determined the devices marketed in interstate commerce prior to May 28, 1976, the stated in the encreasure) to device Amendments, or to devices that have been reclassified in enacultient date of the Medical Dories Fanenal Food, Drug, and Cosmetic Act (Act). You may, accordance with the provisions of the rockers of the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices in controls provisions of the rect menuse required in the mastranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III IT your device is classified (see acc very a to such additional controls. Existing major regulations (Frenaries Approval), it they of subject to outs f Federal Regulations, Title 21, Parts 800 to 895. atrecting your do rios can determination assumes compliance with the current Good A substantially equirement, as set forth in the Quality System Regulation (QS) for Manufacturing Practice requirement, as s c CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to Inspections, the Pood and Drug Administration. In addition, FDA may publish Comply with the GMT regarating your device in the Federal Register. Please note: this fultities alliouncentions concerning your submission does not affect any obligation you might It sponse to your promation in the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) prematet notification. The FDA finding of substantial equivalence of your device to a legally marketed nouticate device results in a classification for your device and thus, permits your device to proceed to the market.
2
Page 2 - Ms. Christine Kuntz-Nassif
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and IT you desire specific advice for your as ic devices), please contact the Office of Compliance at additionally 607.10 for this diagnestions on the promotion and advertising of your device, (2011) 594-4639. prease connact the Orive or Somphares en premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionnies and its into into internation of at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Mark Mckisson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
510(k) Number (if known): K002406
Device Name: Mitek RapidLoc™ Meniscal Repair System
Indications for Use:
The Mitek RapidLoc™ Meniscal Repair System is intended for use in the arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (red-red and red-white zones).
Mark A. Milkersen
Division Sign-Off) (Division Sign-Off)
Division of General, Restorative Division of General Devices Division of Ochoral
And Neurological Devices and Neurological Devices KOO2406
510(k) Number -