(72 days)
Not Found
No
The description focuses on a manual, mechanical suture delivery system and makes no mention of AI or ML.
No.
The device is described as an instrument for mechanically delivering sutures, not for treating a disease or condition. Its intended use is to place sutures.
No
The device is described as an instrument for placing sutures, not for diagnosing conditions or diseases. Its purpose is mechanical delivery of sutures, not information gathering for diagnosis.
No
The device description explicitly states it is an "orthopedic/arthroscopic instrument" and describes physical components like a handle, connector, and suture cartridge, indicating it is a 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 for the "placement of suture(s) through soft tissue in arthroscopic and limited access procedures." This describes a surgical instrument used in vivo (within the body) for a procedural task.
- Device Description: The description clearly states it's an "orthopedic/arthroscopic instrument for mechanically delivering sutures through soft tissue." This further reinforces its use as a surgical tool.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with biological specimens outside the body.
Therefore, the SmartStitch® M-Connector Ultra System is a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SmartStitch® M-Connector Ultra System is indicated for use in the placement of suture(s) through soft tissue in arthroscopic and limited access procedures.
Product codes (comma separated list FDA assigned to the subject device)
NBH, GAT
Device Description
The SmartStitch M-Connector Ultra System is an orthopedic/arthroscopic instrument for mechanically delivering sutures through soft tissue based on the basic design concepts of handheld, manual suture passers.
The handle is provided non-sterile. The connector and suture cartridge are sterilized by ethylene oxide. The finished products are packaged in a Tyvek® pouch inserted into a chipboard carton. Testing was performed to demonstrate the proposed device is substantially equivalent to the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
Bench testing was performed on both the proposed and predicate devices. The test results demonstrate that the SmartStitch M-Connector Ultra System meets all design, performance, and safety specifications. Based on the test results, the proposed device is substantially equivalent to the predicate devices.
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
§ 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
K121306 Page 1/2
510(k) Summary
ArthroCare® Corporation SmartStitch® M-Connector Ultra System
JUL 12 2012
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
General Information
| Submitter Name: | ArthroCare Corporation |
|---|---|
| Address | 7000 West William Cannon Drive |
| Austin, TX 78735 | |
| Contact Person: | Cheryl Frederick |
| Director, Regulatory Affairs | |
| Date Prepared: | April 27, 2012 |
Device System Names/Components
| Proprietary: | SmartStitch M-Connector Ultra | ||
|---|---|---|---|
| Common: | Arthroscopic Instrument | ||
| Classification: | Class I | ||
| Product Code: | NBH | ||
| CFR Section: | 21 CFR 888.1100 | ||
| Proprietary: | SmartStitch Handle | ||
| Common: | Arthroscopic Instrument | ||
| Classification: | Class I | ||
| Product Code: | NBH | ||
| CFR Section: | 21 CFR 888.1100 | ||
| Proprietary: | Suture Cartridge containing MagnumWire® Suture | ||
| Common: | Suture, Nonabsorbable, Synthetic, Polyethylen- | ||
| Classification: | Class II | ||
| Product Code: | GAT | ||
| CFR Section: | 21 CFR 878.5000 |
Predicate Device
The SmartStitch M-Connector Ultra System is substantially equivalent to the ArthroCare M-Connector System cleared under K023843 (February 14, 2003) and K033317 (December 30, 2003), to the ArthroCare PerfectPasser® Connector System cleared under K062244 (October 2, 2006).
Description
The SmartStitch M-Connector Ultra System is an orthopedic/arthroscopic instrument for mechanically delivering sutures through soft tissue based on the basic design concepts of handheld, manual suture passers.
The handle is provided non-sterile. The connector and suture cartridge are sterilized by ethylene oxide. The finished products are packaged in a Tyvek® pouch inserted into a chipboard carton. Testing was performed to demonstrate the proposed device is substantially equivalent to the predicate devices.
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K121306 page 2/2
Intended Use/Indications For Use
The SmartStitch M-Connector Ultra System is indicated for use in the placement of suture(s) through soft tissue in arthroscopic and limited access procedures.
Non-Clinical Data
Bench testing was performed on both the proposed and predicate devices. The test results demonstrate that the SmartStitch M-Connector Ultra System meets all design, performance, and safety specifications. Based on the test results, the proposed device is substantially equivalent to the predicate devices.
Clinical Data
No clinical or animal data are included in this submission.
Summary
All testing demonstrates that the SmartStitch M-Connector Ultra System performs as intended and has acceptable mechanical properties when used in accordance with its labeling. As the SmartStitch M-Connector Ultra System's intended use and technological characteristics are comparable to the predicate devices, we believe that the device is substantially equivalent to the ArthroCare SmartStitch M-Connector System and ArthroCare SmartStitch PerfectPasser System. The minor differences between the subject and predicate devices do not raise any new questions of safety or effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings spread and head turned to the right.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Arthocare Corporation % Ms. Cheryl Frederick Director, Regulatory Affairs 7000 West William Cannon Drive, Building One Austin, Texas 78735
JUL 12 2012
Re: K121306
Trade/Device Name: SmartStitch® M-Connector Ultra System Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly (ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT, NBH Dated: June 25, 2012 Received: June 26, 2012
Dear Ms. Frederick:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Ms. Cheryl Frederick
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours
for
Mark N. Malkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K121306
Device Name: SmartStitch® M-Connector Ultra System
Indications for Use:
The SmartStitch® M-Connector Ultra System is indicated for use in the placement of suture(s) through soft tissue in arthroscopic and limited access procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Daniel Krone for MAY.
(Division Sign-Off)
Division of Surgical. Orthopedic, and Restorative Devices
510(k) Number K121306
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