(109 days)
Not Found
No
The device description explicitly states it is a "manually operated" system, and there are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML development and validation.
No.
The CapSew™ Plication System is intended for placing sutures through soft tissue during surgical procedures, specifically for shoulder capsule tightening. It is a surgical tool, not a device used to treat a disease or condition therapeutically.
No
The device is described as a "suture placement system" used for "shoulder capsule tightening (plication) procedures." Its purpose is to place suture through soft tissue during surgical procedures, which is a therapeutic or interventional action, not a diagnostic one.
No
The device description explicitly states it is a "sterile hand-held, manually operated, single procedure suture placement system" and includes physical components like a "Plication Handle with mounted Suture Cartridge" and an additional "Suture Cartridge." This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "placement of suture through soft tissue in arthroscopic and open surgical procedures including shoulder capsule tightening." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The device is described as a "sterile hand-held, manually operated, single procedure suture placement system." This is a surgical instrument, not a device used for analyzing biological samples.
- Anatomical Site: The anatomical site is the "shoulder capsule," which is a part of the human body being surgically treated.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on laboratory tests.
In summary, the CapSew™ Plication System is a surgical device used for performing a procedure, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The CapSew™ Plication System is intended for use in placement of suture through soft tissue in arthroscopic and open surgical procedures including shoulder capsule tightening.
Product codes
GAT
Device Description
The CapSew™ Plication System is a sterile hand-held, manually operated, single procedure suture placement system for shoulder capsule tightening (plication) procedures. The CapSew Plication System includes one CapSew Plication Device (consisting of a Plication Handle with mounted Suture Cartridge) and one additional CapSew™ Suture Cartridge.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, shoulder capsule
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)
Mechanical testing has been conducted and data was submitted to demonstrate that the performance of the CapSew™ Plication System is equivalent to that of predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K042031, K041894, K063778, K001434
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
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K071796 page 1/2
510(k) Premarket Notification
CapSew™ Plication System
510(k) Summary
0CT 1 9 2007
Cayenne Medical, Inc. CapSew™ Plication System
ADMINISTRATIVE INFORMATION
Manufacturer Name: Cayenne Medical, Inc. 16597 North 92nd Street, Suite 101 Scottsdale, AZ 85260 USA Telephone +1 (480) 502-3661 Fax +1 (480) 502-3670
Official Contact:
Derek Harper
Representative/Consultant:
David J. Collette MD or Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone 1 (858) 792-1235 Fax 1 (858) 792-1236 email: dcollette@paxmed.com flarson@paxmed.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name: Classification Regulations: Product Codes Classification Panel: Reviewing Branch:
CapSew™ Plication System Suture punch, endoscopic accessories 21 CFR 878.5000, Class II GAT General and Plastic Surgery General and Plastic Surgery
INTENDED USE
The CapSew™ Plication System is intended for use in placement of suture through soft tissue in arthroscopic and open surgical procedures including shoulder capsule tightening.
1
K07179
ge 2/2
CapSew " Plication System
DEVICE DESCRIPTION
The CapSew"" Plication System is a sterile hand-held, manually operated, single procedure suture placement system for shoulder capsule tightening (plication) procedures. The CapSew Plication System includes one CapSew Plication Device (consisting of a Plication Handle with mounted Suture Cartridge) and one additional CapSew" Suture Cartridge.
PERFORMANCE TESTING
Mechanical testing has been conducted and data was submitted to demonstrate that the performance of the CapSew™ Plication System is equivalent to that of predicate devices.
EQUIVALENCE TO MARKETED PRODUCT
Cayenne Medical, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the CapSew" Plication System is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices: Opus Medical, Inc.'s Opus SpeedStitch™ Suture Device (K042031), CP Medical's CP Fiber, Non-Absorbable Polyblend Surgical Suture (K041894), Teleflex Medical's Force Fiber® Polyethylene Non-Absorbable Surgical Suture (K063778), and Genzyme Surgical Products Polyester Nonabsorbable Surgical Suture (K001434).
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles embedded within its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
JAN - 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cayenne Medical, Inc % PaxMed International, LLC David J. Collette, MD Regulatory Affairs 11234 El Camino Real, Suite 200 San Diego, California 92130
Re: K071796
Trade/Device Name: CapSew™ Plication System Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: September 26, 2007 Received: October 1, 2007
Dear Dr. Collette:
This letter corrects our substantially equivalent letter of October 19, 2007.
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
3
Page 2 - David J. Collette, MD
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.
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) 276-0115. 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 Prostmarket, 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 yours,
Mark A. Milliken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
CapSew™ Plication System Device Name:
Indications for Use:
The CapSew™ Plication System is intended for use in placement of suture through soft tissue in arthroscopic and open surgical procedures.
Maida A. Milhersen
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K071796
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
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