(79 days)
Not Found
No
The summary describes a mechanical surgical device and its components, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for the "arthroscopic fixation of longitudinal vertical meniscus lesions," which is a treatment for a medical condition.
No
The device, RAPIDLOC-PDS Meniscal Repair System, is described as a "bioabsorbable meniscal tissue fixation implant" used for "arthroscopic fixation of longitudinal vertical meniscus lesions." This indicates it is a therapeutic device designed for repair and treatment, not for diagnosing conditions.
No
The device description clearly outlines physical components (implant, suture, needle, pusher) and does not mention any software as a component of the system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The RAPIDLOC-PDS Meniscal Repair System is a surgical implant and delivery system used to physically repair a torn meniscus within the knee joint. It is applied directly to the tissue inside the body.
- Intended Use: The intended use is to fix a meniscus lesion, which is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The information provided clearly describes a surgical device used for repair, not a diagnostic test performed on a biological sample.
N/A
Intended Use / Indications for Use
The RAPIDLOC-PDS 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 areas).
Product codes (comma separated list FDA assigned to the subject device)
87 MAI, JDR
Device Description
The RAPIDLOC-PDS Meniscal Repair System consists of a two piece (polydiaxonone tophat and polylactic acid backstop) bioabsorbable meniscal tissue fixation implant mounted on a 2/0 pre-knotted PANACRYL braided long-term absorbable suture. It is applied using a cannulated needle and arthroscopic pusher.
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)
Testing conducted to characterize performance of the RAPIDLOC-PDS Meniscal Repair System has demonstrated that it is substantially equivalent to the predicate devices and is suitable for the intended use specified.
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.
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
DEC 2 7 2002
23388
510(k) Summary (page 1 of 2)
Submitter's Name and Address:
Mitek Worldwide 249 Vanderbilt Avenue Norwood, MA 02062 Registration #1221934
Petra Smit, RAC, Sr. Project Manager Regulatory Affairs
781-251-3196 781-278-9578
October 8, 2002
Date Summary Prepared:
Device Trade Name:
Contact Person:
Phone Number:
Telefax Number:
Common name:
Classification Name:
Predicate Device(s):
Device Description:
Intended Use:
Mitek RAPIDLOC-PDS Meniscal Repair System
Biodegradable Fixation Fastener
Fastener, Fixation, Biodegradable Soft Tissue (Class II, 21 CFR 888.3030, Product code: 87 MAI)
RAPIDLOC Meniscal Repair System (K002406) Mitek "H"-Fix Meniscal Fastener (K970119)
The RAPIDLOC-PDS Meniscal Repair System consists of a two piece (polydiaxonone tophat and polylactic acid backstop) bioabsorbable meniscal tissue fixation implant mounted on a 2/0 pre-knotted PANACRYL braided long-term absorbable suture. It is applied using a cannulated needle and arthroscopic pusher.
The RAPIDLOC-PDS Meniscal Repair System is intended for use in the arthroscopic fixation of longitudinal vertical meniscus lesions (buckethandle lesions) located in the vascularized area of the meniscus (red-red and red-white areas).
SPECIAL 510(K)-PREMARKET NOTIFICATION: DEVICE MODIFICATION MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM
1
510(k) Summary (page 2 of 2)
| Technological Characteristics: | The proposed device has similar technological
characteristics and is similar in design and
configuration compared to the predicate devices. |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Non-clinical Test: | Testing conducted to characterize performance
of the RAPIDLOC-PDS Meniscal Repair
System has demonstrated that it is substantially
equivalent to the predicate devices and is
suitable for the intended use specified. |
| Clinical Data: | Not Applicable |
| Conclusion: | Based on 1) safety and performance data, and 2)
similarities in design, operating principles,
biocompatibility and sterilization method, The
Mitek RAPIDLOC-PDS Meniscal Repair
System has been shown to be substantially
equivalent to predicate devices under the. |
.
SPECIAL 510(K)-PREMARKET NOTIFICATION: DEVICE MODIFICATION MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM
Federal Food, Drug and Cosmetic Act.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract eagle design, with three stylized lines forming the body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OFC 2 7 2002
Ms. Petra C. Smit Sr. Project Manager, Regulatory Affairs Mitek Worldwide 249 Vanderbilt Avenue Norwood, Massachusetts 02062
Re: K023388
Trade/Device Name: Mitek RAPIDLOC-PDS Meniscal Repair System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: JDR Dated: December 5, 2002 Received: December 6, 2002
Dear Ms. Smit:
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 application (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. Iisting 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 such 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.
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.
3
Page 2 - Ms. Petra Smit
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 contact the Office of Compliance at (301) 594-4659. 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 premarket notification" (21CFR Part 807.97). 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,
Mark M. Mulkerson
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
4
Page 1 of 1
510(k) Number (if known):
Device Name: RAPIDLOC-PDS Meniscal Repair System
Indications for Use:
The RAPIDLOC-PDS 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 areas).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Mellema
Division of General, Restorative and Neurological Decrees
510(k) Number: K023388
Prescription Use 7 4 (Per 21 CFR 801.109)
OR
Over-the-Counter Use No