(136 days)
Not Found
No
The description explicitly states the device is "manually operated" and there are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML development.
No
The device is described as a "suture placement system" intended for "approximation of soft tissue," which is a surgical tool, not a therapeutic device designed for treatment or healing itself.
No
The device is described as a "suture placement system for soft tissue approximation procedures" and "intended for approximation of soft tissue in procedures such as meniscal repair," which indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description explicitly states it is a "sterile hand-held, manually operated single procedure suture placement system," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "approximation of soft tissue in procedures such as meniscal repair." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "sterile hand-held, manually operated single procedure suture placement system." This is a surgical instrument used to manipulate tissue and place sutures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratories or point-of-care settings to analyze biological samples.
The device is clearly a surgical tool used for tissue repair, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Dual Needle Suture Passer System is intended for approximation of soft tissue in procedures such as meniscal repair.
Product codes (comma separated list FDA assigned to the subject device)
GAT
Device Description
The Dual Needle Suture Passer System is a sterile hand-held, manually operated single procedure suture placement system for soft tissue approximation procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, meniscal
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 suture knot pull-out force testing has been conducted on the Dual Needle Suture Passer System. It was shown that suture knot pull-out strength is significantly higher than that of a predicate device. The proposed device was tested in the animal tissue and meets the knot pull-out strength requirements. The proposed device meets USP requirements for non-absorbable sutures.
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.
K063778, K041894, K023388, K062307, K072322
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
§ 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.
0
Dual Needle Suture Passer
Page 1 of 2
510(k) Premarket Notification
Dual Needle Suture Passer
510(k) Summary
Cayenne Medical, Inc. Dual Needle Suture Passer System JAN 1 6 2009
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Cayenne Medical Inc
16597 N 92nd St, Suite 101
Scottsdale, AZ 85260
Telephone (480) 502-3661
FAX (480) 502-3670 |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Kereshmeh Shahriari
16597 N 92nd St, Suite 101
Scottsdale AZ 85260
kshahriari@cayennemedical.com
Telephone (480) 502-3661
FAX (480) 502-3670 |
DEVICE NAME
| Classification Names | Suture, Nonabsorbable, Synthetic, Polyethylene |
|---|---|
| Trade/Proprietary Name | Dual Needle Suture Passer System |
| Common Name | Suture Punch, Endoscopic Accessories |
DEVICE CLASSIFICATION
FDA has classified sutures as Class II devices (21 CFR 878 5000) The product code for Suture, Nonabsorbable, Synthetic, Polyethylene is GAT These devices are reviewed by the General and Plastic Surgery Branch
INTENDED USE
The Dual Needle Suture Passer System is intended for approximation of soft tissue in procedures such as memscal repair
DANGER!
Page 109 & 110
1
Dual Needle Suture Passer
Response,
Page ② of ②
510(k) Premarket Notification
Dual Needle Suture Passer
DEVICE DESCRIPTION
The Dual Needle Suture Passer System is a sterle hand-held, manually operated sungle procedure suture placement system for soft tissue approximation procedures
Mechanical suture knot pull-out force testing has been conducted on the Dual Needle Suture Passer System It was shown that suture knot pull-out strength is significantly higher than that of a predicate device The proposed device was tested in the animal trsue and meets the knot pull-out strength requirements The proposed device meets USP requirements for non-absorbable sutures
EQUIVALENCE TO MARKETED PRODUCT
Cayenne Medical, Inc demonstrated that for the purposes of FDA's regulation of medical devices, the Dual Needle Suture Passer System is substantially equivalent 111 indications and design principles to predicate devices each of which has been determined by FDA to be substantially equivalent to preamendment devices Teleflex Medical's Force Fiber™, Non-absorbable Polyethylene Surgical Suture (K063778), CP Medical's CP Fiber Non-absorbable Polyblended Surgical Suture (K041894), DePuy Mitek's (Mitek Worldwide) RAPIDLOC-PDS Mensical Repair System (K023388), Anulex Technologies's Xclose™ Tissue Repair System (K062307), and Smith & Nephew s ULTRA FAST-FIX Memscal Repair System (K072322)
Revised Page 18 of 161
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
Food and Drug Admınıstration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 2009
Cayenne Medical, Inc % Kereshmeh Shahrıarı Director of QA & RA 16597 N 92nd Street, Suite 101 Scottsdale, Arizona 85260
Re K082518
Trade/Device Name Dual Needle Suture Passer System Regulation Number 21 CFR 878 5000 Regulation Name Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class II Product Code GAT Dated December 22, 2008 Received December 23, 2008
Dear Kereshmeh Shahrıarı
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 pror 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
and the stille
all to the mail be a chiefic to and the legist of the leating the
2017-12-11-11
3
Page 2 - Kereshmeh Shahrıarı
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 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 yours.
Mark N Millican
Mark N Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
17000558
510(k) Premarket Notification
Dual Needle Suture Passer
Indications for Use
510(k) Number (if known) K072518
Device Name Dual Needle Suture Passer System
Indications for Use
The Dual Needle Suture Passer System is intended for approximation of soft tissue 11 procedures such as meniscal repar
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)
서 대한민국 대학교 대학교 대학교 대학교 대학교 대학교 대학교 대학교 대학교 대학교 대학교 대학교 대학교 대학교 대학교 대학교 대학교 대학교
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| (Division Sign-Off) |
|---|
| Division of General, Restorative, |
| and Neurological Devices |
| 510(k) Number | 16082518 |
|---|---|
| --------------- | ---------- |