(163 days)
The CAIS Staple is an absorbable implant used in the fixation of periosteal autograft to articular cartilage lesions of the knee.
The CAIS Staple is a PDS implant that attaches a scaffold to articular cartilage lesions in the knee.
The provided text describes a 510(k) summary for the CAIS Staple, a medical device. However, it does not contain any information regarding specific acceptance criteria, performance metrics, or details of a study that proves the device meets such criteria.
The document establishes substantial equivalence to a predicate device (PDS/PGA Staple, K021953) based on indications for use, technological characteristics, and comparison. It states "Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices," but does not provide any specific data, test results, or study methodologies.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth and their qualifications: Not mentioned.
- Adjudication method: Not mentioned.
- MRMC comparative effectiveness study: Not mentioned.
- Standalone performance study: Not mentioned.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
This 510(k) summary is a regulatory document focused on demonstrating substantial equivalence rather than detailing scientific studies with specific performance metrics against pre-defined acceptance criteria.
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K073281 (pg 1 of 2)
:
510(k) SUMMARY
CAIS Staple
| Submitter's Name andAddress: | DePuy Mitek, a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767 |
|---|---|
| Contact Person | Ruth C. ForstadtProject Manager, Regulatory AffairsDePuy Mitek, a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767Telephone:508-977-3988Facsimile:508-828-3750e-mail:rforstad@dpyus.jnj.com |
| Name of Medical Device | Proprietary Name: CAIS Staple |
| Substantial Equivalence | CAIS Staple is substantially equivalent to: PDS/PGA Staple (K021953) |
| Device Classification | Classification Name: Single/multiple component metallic bonefixation appliances and accessories(21 CFR 888.3030), Product code: 87 JDR |
| Common/Usual Name: Staple, fixation, bone | |
| Device Description | The CAIS Staple is a PDS implant that attaches a scaffold to articularcartilage lesions in the knee. |
| Indications for Use | The CAIS Staple is an absorbable implant used in the fixation ofperiosteal autograft to articular cartilage lesions of the knee. |
| Safety and Performance | Results of performance and safety testing have demonstrated that themodified device is substantially equivalent to the predicate devices. |
| Based on the indications for use, technological characteristics, andcomparison to predicate devices, the CAIS Staple has been shown to besubstantially equivalent to predicate devices under the Federal Food,Drug and Cosmetic Act. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Mitek a Johnson & Johnson Company % Ms. Ruth C. Forstadt 325 Paramount Drive Raynham, MA 02767
MAY - 2 2000
Re: K073281 Trade/Device Name: CAIS Staple 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: April 2, 2008 Received: April 3, 2008
Dear Ms. Forstadt:
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, 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 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.
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Page 2 - Ms. Ruth C. Forstadt
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Mark M. Miller
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): _ KO 7328|
Device Name: CAIS Staple
The CAIS Staple is an absorbable implant used in the fixation of periosteal autograft to articular cartilage lesions of the knee.
Prescription Use V (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)
Page 1 of ______
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | 16073281 |
|---|---|
| --------------- | ---------- |
§ 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.