(119 days)
Not Found
No
The device description and performance studies focus on mechanical function and material properties, with no mention of AI or ML.
No
This device is a surgical instrument used to assist in the placement of sutures and surgical mesh, which are mechanical actions rather than therapeutic interventions that directly treat a disease or condition.
No
The device is a surgical instrument designed to assist in "placement of suture material in tissues" and "insertion or anchoring of surgical mesh." Its function is entirely mechanical and procedural, not diagnostic.
No
The device description clearly details a physical, sterile, single-use instrument with a plunger, shaft, and needle driver, indicating it is a hardware device.
Based on the provided information, the Capio™ SLIM Suture Capturing Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical instrument used to assist in placing sutures and surgical mesh during surgery on living tissue. This is an in-vivo application, not an in-vitro (outside the body) diagnostic test.
- Device Description: The description details a mechanical device for manipulating sutures and needles within the body during a surgical procedure. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic results.
The device is a surgical tool used for mechanical manipulation of tissues and materials during a surgical procedure.
N/A
Intended Use / Indications for Use
The Capio™ SLIM Suture Capturing Device is intended for use in general suturing applications during surgery to assist in the placement of suture material in tissues at the operative site. The Capio™ SLIM Suture Capturing Device is to be used with sensory and/or direct visual control.
The Capio SLIM Suture Capturing Device is also intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures.
Product codes (comma separated list FDA assigned to the subject device)
PWI
Device Description
The Capio™ SLIM Suture Capturing Device is urogynecologic mesh instrumentation used with urogynecologic surgical mesh. The subject device is also intended for use in general suturing applications during surgery to assist in placement of suture material in tissues, and assist in insertion or anchoring of surgical mesh for transabdominal pelvic organ prolapse repair.
The Capio™ SLIM Suture Capturing Device is a sterile, single use device and is designed to be used by the physician to facilitate the placement of sutures in difficult to access locations during open surgical procedures. The Capio™ SLIM device is also designed to throw, catch and retrieve sutures in one step. The device consists of a one-handactivated plunger at the proximal end, a tubular shaft and a curved needle driver at the distal end. Depressing the plunger actuates the carrier and drives the suture/dart through the tissue. The needle is automatically caught by the device's needle catch mechanism for easy suture tying, or the device may be re-loaded for additional suture throws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / during surgery
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)
The following tests were performed to demonstrate that the proposed Capio Slim Device met the applicable design and performance requirements and support a determination of substantial equivalence under the specified testing parameters. These tests include:
Sterilization Validation
Package integrity testing following real-time aging
o Dve Penetration
o Seal Strength
o Visual Inspection
Dimensional Test ●
Functional Test ●
Compression Test
Tip Tensile Test ●
Side Load Deflection
Top Load Deflection ●
Needle Retention Test ●
Catch Pull Test
Actuation Test
Distribution Challenge of Packaging
Biocompatibility ●
o Cytotoxicity
o Sensitization
Irritation or Intracutaneous Reactivity O
o Acute systemic toxicity
o Material-Mediated Pyrogenicity
Shelf-life Testing ●
The results of performance testing demonstrate the Capio SLIM Suture Capturing Device is biocompatible, has sufficient mechanical performance for its intended use, and supports a three-year shelf life.
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
§ 884.4910 Specialized surgical instrumentation for use with urogynecologic surgical mesh.
(a)
Identification. Specialized surgical instrumentation for use with urogynecologic surgical mesh is a prescription device specifically intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures. These procedures include transvaginal pelvic organ prolapse repair, sacrocolpopexy (transabdominal pelvic organ prolapse repair), and treatment of female stress urinary incontinence. Examples of specialized surgical instrumentation include needle passers and trocars, needle guides, fixation tools, and tissue anchors. This device is not a manual gastroenterology-urology surgical instrument and accessories (§ 876.4730) or a manual surgical instrument for general use (§ 878.4800).(b)
Classification. Class II (special controls). The special controls for specialized surgical instrumentation for use with urogynecologic surgical mesh are:(1) The device must be demonstrated to be biocompatible;
(2) The device must be demonstrated to be sterile and, if reusable, it must be demonstrated that the device can be adequately reprocessed;
(3) Performance data must support the shelf life of the device by demonstrating package integrity and device functionality over the requested shelf life;
(4) Non-clinical performance testing must demonstrate that the device meets all design specifications and performance requirements, and that the device performs as intended under anticipated conditions of use; and
(5) Labeling must include:
(i) Information regarding the mesh design that may be used with the device;
(ii) Detailed summary of the clinical evaluations pertinent to use of the device;
(iii) Expiration date; and
(iv) Where components are intended to be sterilized by the user prior to initial use and/or are reusable, validated methods and instructions for sterilization and/or reprocessing of any reusable components.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 3, 2017
Boston Scientific Corporation Michelle Becker Regulatory Affairs Specialist Urology and Pelvic Health 100 Boston Scientific Way Marlborough, Massachusetts 01752
Re: K172060
Trade/Device Name: Capio™ SLIM Suture Capturing Device Regulation Number: 21 CFR 884.4910 Regulation Name: Specialized surgical instrumentation for use with urogynecologic surgical mesh Regulatory Class: Class II Product Code: PWI Dated: September 29, 2017 Received: October 2, 2017
Dear Michelle Becker:
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
1
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); medical device 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172060
Device Name Capio™ SLIM Suture Capturing Device
Indications for Use (Describe)
The Capio™ SLIM Suture Capturing Device is intended for use in general suturing applications during surgery to assist in the placement of suture material in tissues at the operative site. The Capio™ SLIM Suture Capturing Device is to be used with sensory and/or direct visual control.
The Capio SLIM Suture Capturing Device is also intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ✖ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary for Capio™ SLIM Suture Capturing Device (K172060)
A. Date Prepared
November 2, 2017
B. Sponsor
Boston Scientific Corporation Urology and Pelvic Health Division 100 Boston Scientific Way Marlborough, MA 01752
C. Contact
Rachel Nankervis Specialist I, Regulatory Affairs Phone: 508-683-4755 Fax: 508-683-5041 Rachel.Nankervis@bsci.com
Or
Michelle Becker Principal Specialist, Regulatory Affairs Phone: 508-210-6988 Fax: 508-683-5041 Michelle.Becker@bsci.com
D. Device Name
Trade Name: Capio™ SLIM Suture Capturing Device Common/usual Name: Suture Placement Device Regulation Number: 21 CFR 884.4910 Regulation Name: Specialized surgical instrumentation for use with urogynecologic surgical mesh Classification: Class II Product Code: PWI
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E. Predicate Device(s)
Trade Name: Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support System Common/usual Name: Surgical Mesh for transvaginal pelvic organ prolapse repair Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Classification: II Product Code: OTP Premarket Notification: K122459
F. Device Description
The Capio™ SLIM Suture Capturing Device is urogynecologic mesh instrumentation used with urogynecologic surgical mesh. The subject device is also intended for use in general suturing applications during surgery to assist in placement of suture material in tissues, and assist in insertion or anchoring of surgical mesh for transabdominal pelvic organ prolapse repair.
The Capio™ SLIM Suture Capturing Device is a sterile, single use device and is designed to be used by the physician to facilitate the placement of sutures in difficult to access locations during open surgical procedures. The Capio™ SLIM device is also designed to throw, catch and retrieve sutures in one step. The device consists of a one-handactivated plunger at the proximal end, a tubular shaft and a curved needle driver at the distal end. Depressing the plunger actuates the carrier and drives the suture/dart through the tissue. The needle is automatically caught by the device's needle catch mechanism for easy suture tying, or the device may be re-loaded for additional suture throws.
G. Comparison of Intended Use with Predicate Device
| K172060 (Subject Device) | K122459 (Predicate Device) | |
|---|---|---|
| Indications | ||
| for Use | The Capio™ SLIM Suture Capturing | |
| Device is intended for use in general | ||
| suturing applications during surgery to | ||
| assist in the placement of suture | ||
| material in tissues at the operative site. | ||
| The Capio™ SLIM Suture Capturing | ||
| Device is to be used with sensory | ||
| and/or direct visual control. |
The Capio SLIM Suture Capturing
Device is also intended for use as an | The Pinnacle Lite Pelvic Floor Repair
Kit is indicated for tissue reinforcement
in women with pelvic organ prolapse, for
transvaginal repair of posterior vaginal
vault prolapse.
The Uphold Lite Vaginal Support System
is indicated for tissue reinforcement in
women with pelvic organ prolapse, for
transvaginal repair of anterior and apical
vaginal vault prolapse |
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| aid in the insertion, placement, | |
|---|---|
| fixation, or anchoring of surgical mesh | |
| during urogynecologic procedures. |
The indications for use statements for subject device and the predicate device are not identical, as the predicate device is a surgical mesh that is indicated pelvic to treat organ prolapse. The intended use of the subject and predicate device is the same, as the subject device is an accessory to a surgical mesh.
| Device(s): | K172060 (Subject Device) | K122459 (Predicate Device) |
|---|---|---|
| General Device Characteristics | ||
| Patient | ||
| contact |