(169 days)
Not Found
No
The device description focuses on mechanical components and suture materials. There is no mention of AI, ML, or any computational processing that would suggest the use of such technologies. The performance studies are bench tests of mechanical properties.
No
The device is a surgical instrument used for suturing, which is a procedure rather than a therapeutic treatment in itself. Its purpose is to physically close tissue during surgery, not to treat a condition directly.
No
The device is a surgical suturing system used for placing stitches in soft tissue during minimally invasive surgeries. It is a tool for performing a medical procedure, not for diagnosing conditions or diseases.
No
The device description clearly outlines physical components: a reusable suturing device with a shaft and end effector, and single-use suture cartridges containing needles and sutures. The performance studies also focus on bench testing of these physical components. There is no mention of software as a primary or standalone component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "suturing in minimally invasive surgeries" and "placement of interrupted or running stitches in soft tissue." This describes a surgical tool used directly on a patient's tissue during a procedure.
- Device Description: The description details a mechanical device (suturing device) and associated materials (suture cartridges) used for physically joining tissue.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro (outside the body) to examine specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The provided information does not mention any analysis of biological samples or diagnostic purposes.
The device is clearly a surgical instrument used for a therapeutic purpose (closing wounds/tissue) rather than a diagnostic purpose.
N/A
Intended Use / Indications for Use
The PROXISURE™ Suturing Device, ETHIBOND™ Suture Cartridge, and Coated VICRYL™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue.
The PROXISURE™ Suturing Device and ETHIBOND™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue.
The PROXISURE™ Suturing Device and Coated VICRYL™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
GAM, GAT, OCW
Device Description
The PROXISURE™ Suturing System is composed of a reusable PROXISURE™ Suturing Device and single-use, sterile Suture Cartridges that are used for placement of interrupted or running stitches in soft tissue. The Suturing Device has a stationary shaft that has an articulating and rotating end effector. The device is reusable and must be cleaned and sterilized by the end user per the cleaning, disinfection, and sterilization instructions provided in the Instructions for Use before and between uses. A Suture Cartridge is loaded at the distal tip of the end effector which contains the needle and suture for use during the surgical procedures.
The PROXISURE ™ Suture Cartridges are designed for use with the PROXISURE™ Suturing Device and are available with two types of sutures in three sizes each. The suture material is commercially available Coated VICRYL™ and ETHIBOND EXCEL™ sutures. ETHIBOND™ Suture is dyed green with D&C Green #6 (Color Index No. 61565) to enhance visibility in the surgical field. ETHIBOND Suture complies with the requirements of the European Pharmacopoeia (Ph. Eur.) for sterile poly(ethylene terephthalate) Suture and the United States Pharmacopoeia (USP) for Non-Absorbable Surgical Sutures. Coated VICRYL™ Sutures that come with the Suture Cartridge are dyed by adding D+C violet #2 (Color Index number: 60725) during polymerization. Coated VICRYL™ Suture complies with the requirements of the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopoeia (USP) for Sterile Synthetic Absorbable Braided Sutures, except for an occasional slight oversize in the gauges for the suture cartridge. The PROXISURE™ Suturing Device and the Suture Cartridges are packaged separately and will be available for assembly prior to use at the surgical site.
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 to verify the performance of the subject device meets the definition of substantial equivalence to the predicate device and the device will perform as intended. Bench testing included needle passing reliability testing, needle passing and tissue sticking testing, knot strength testing, needle pull off strength, suture manipulation needle release, cartridge cage pullback, needle release force and end effector features testing.
The conclusions of the testing criteria demonstrate the subject device performs substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness.
This submission does not include data from Clinical Studies.
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
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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
Image /page/0/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 3, 2016
Ethicon Endo-Surgery, Inc. Ms. Rubina Dosani, M.S. Sr. Regulatory Affairs Project Lead 4545 Creek Road Cincinnati, OH 45242
Re: K153611
Trade/Device Name: Coated VICRYL (Polyglactin 910)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/l-lactide) surgical suture Regulatory Class: Class II Product Code: GAM, GAT, OCW Dated: May 3, 2016 Received: May 5, 2016
Dear Ms. Dosani:
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
1
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 and 809); 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153611
Device Name PROXISURE™ Suturing Device ETHIBOND™ Suture Cartridge Coated VICRYL™ Suture Cartridge
Indications for Use (Describe)
The PROXISURE™ Suturing Device, ETHIBOND™ Suture Cartridge, and Coated VICRYL™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue.
The PROXISURE™ Suturing Device and ETHIBOND™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue.
The PROXISURE™ Suturing Device and Coated VICRYL™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
510(k) Summary
| Submitter Information: | Ethicon, LLC |
|---|---|
| 475 C Street | |
| Guaynabo, PR 00969 |
Application Correspondent
Rubina Dosani Sr. Regulatory Affairs Project Lead Ethicon Endo-Surgery, Inc. Telephone: Fax: Email: rdosani@its.jnj.com
Date Prepared December 16, 2015
PROXISURE™ Suturing System which includes the following components: PROXISURE™ Suturing Device, Coated VICRYLTM Suture Cartridge, ETHIBOND™ Suture Cartridge.
| Device Trade Name: | PROXISURE™ Suturing Device |
|---|---|
| Device Common Name: | Endoscopic Suturing Device |
| Classification Regulation: | 21 CFR 876.1500 |
| Device Class: | II |
| Panel: | General & Plastic Surgery |
| Product Code: | OCW |
| Device Trade Name: | Coated VICRYL™ Suture Cartridge |
| Device Common Name: | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Classification Regulation: | 21 CFR 878.4493 |
| Device Class: | II |
| Panel: | General & Plastic Surgery |
| Product Code: | GAM |
| Device Trade Name: | ETHIBOND™ Suture Cartridge |
| Device Common Name: | Suture, Non-Absorbable, Synthetic, Polyethylene |
| Classification Regulation: | 21 CFR 878.5000 |
| Device Class: | II |
| Panel: | General & Plastic Surgery |
| Product Code: | GAT |
| Predicate Devices: | Modified Endo Stitch™ (K082659) |
| Coated VICRYL™ (Polyglactin 910) Sterile Synthetic | |
| Absorbable Suture (K022269) | |
| ETHIBOND EXCEL™ Polybutlylate Coated Polyester Sterile | |
| Synthetic Non-Absorbable Suture (K946173) |
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K153611, Page 2 of 3
Device Description
The PROXISURE™ Suturing System is composed of a reusable PROXISURE™ Suturing Device and single-use, sterile Suture Cartridges that are used for placement of interrupted or running stitches in soft tissue. The Suturing Device has a stationary shaft that has an articulating and rotating end effector. The device is reusable and must be cleaned and sterilized by the end user per the cleaning, disinfection, and sterilization instructions provided in the Instructions for Use before and between uses. A Suture Cartridge is loaded at the distal tip of the end effector which contains the needle and suture for use during the surgical procedures.
The PROXISURE ™ Suture Cartridges are designed for use with the PROXISURE™ Suturing Device and are available with two types of sutures in three sizes each. The suture material is commercially available Coated VICRYL™ and ETHIBOND EXCEL™ sutures. ETHIBOND™ Suture is dyed green with D&C Green #6 (Color Index No. 61565) to enhance visibility in the surgical field. ETHIBOND Suture complies with the requirements of the European Pharmacopoeia (Ph. Eur.) for sterile poly(ethylene terephthalate) Suture and the United States Pharmacopoeia (USP) for Non-Absorbable Surgical Sutures. Coated VICRYL™ Sutures that come with the Suture Cartridge are dyed by adding D+C violet #2 (Color Index number: 60725) during polymerization. Coated VICRYL™ Suture complies with the requirements of the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopoeia (USP) for Sterile Synthetic Absorbable Braided Sutures, except for an occasional slight oversize in the gauges for the suture cartridge. The PROXISURE™ Suturing Device and the Suture Cartridges are packaged separately and will be available for assembly prior to use at the surgical site.
Indications for Use for the components of the PROXISURE™ Suturing System
The PROXISURE™ Suturing Device, ETHIBOND™ Suture Cartridge and Coated VICRYL™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue.
The PROXISURE™ Suturing Device and ETHIBOND™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue.
The PROXISURE™ Suturing Device and Coated VICRYL™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue.
5
Substantial Equivalence Summary
The subject and predicate devices have the same intended use and primary surgical use - suturing in minimally invasive surgeries with applications for the placement of interrupted or running stitches in soft tissue. Both subject and predicate devices are mechanical devices where no energy passes through to the patient, are not battery operated and do not use software.
Technological Characteristics
The suturing device is composed of a reusable handle and shaft with a rotating and articulating distal end effector. The working length of the suturing device is 40 cm with a 12mm diameter which will fit through a 12mm trocar. A single-use, sterile Suture Cartridge is loaded at the distal tip of the end effector containing the needle and suture for use during surgical procedures.
Performance Data
Bench testing was performed to verify the performance of the subject device meets the definition of substantial equivalence to the predicate device and the device will perform as intended. Bench testing included needle passing reliability testing, needle passing and tissue sticking testing, knot strength testing, needle pull off strength, suture manipulation needle release, cartridge cage pullback, needle release force and end effector features testing.
The conclusions of the testing criteria demonstrate the subject device performs substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness.
This submission does not include data from Clinical Studies.