(163 days)
No
The summary describes a physical implant (staple) and does not mention any software, algorithms, or data processing related to AI/ML.
Yes
The device is used for fixation of periosteal autograft to articular cartilage lesions of the knee, which is a therapeutic intervention.
No
Explanation: The device is described as an absorbable implant used for fixation, which indicates a therapeutic or surgical purpose rather than a diagnostic one.
No
The device description explicitly states it is an "absorbable implant" and a "PDS implant," indicating it is a physical hardware 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 is the "fixation of periosteal autograft to articular cartilage lesions of the knee." This describes a surgical procedure involving an implant, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is described as an "absorbable implant" and a "PDS implant that attaches a scaffold to articular cartilage lesions in the knee." This further confirms it's a physical device used within the body during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The CAIS Staple is an absorbable implant used in the fixation of periosteal autograft to articular cartilage lesions of the knee.
Product codes
87 JDR
Device Description
The CAIS Staple is a PDS implant that attaches a scaffold to articular cartilage lesions in the knee.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices.
Based on the indications for use, technological characteristics, and comparison to predicate devices, the CAIS Staple has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PDS/PGA Staple (K021953)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K073281 (pg 1 of 2)
:
510(k) SUMMARY
CAIS Staple
| Submitter's Name and
Address: | DePuy Mitek, a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ruth C. Forstadt
Project Manager, Regulatory Affairs
DePuy Mitek, a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767
Telephone:
508-977-3988
Facsimile:
508-828-3750
e-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 bone
fixation 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 articular
cartilage lesions in the knee. |
| Indications for Use | The CAIS Staple is an absorbable implant used in the fixation of
periosteal autograft to articular cartilage lesions of the knee. |
| Safety and Performance | Results of performance and safety testing have demonstrated that the
modified device is substantially equivalent to the predicate devices. |
| | Based on the indications for use, technological characteristics, and
comparison to predicate devices, the CAIS Staple has been shown to be
substantially equivalent to predicate devices under the Federal Food,
Drug and Cosmetic Act. |
1
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.
2
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
3
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 |
|---|---|
| --------------- | ---------- |