(29 days)
Not Found
No
The device description and performance studies focus on the mechanical function of a wound retraction device, with no mention of AI or ML.
No
The device is described as a wound retraction device used to provide access and protection during surgery, not to treat a disease or condition.
No
The device is described as a wound retraction device used to provide access and protection during surgery, not to diagnose a condition.
No
The device description and performance studies clearly indicate a physical wound retraction device with rings and film, not a software-only product.
Based on the provided information, the Surgisleeve™ Wound Protector is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a device used during surgery to access and protect body cavities (abdominal and thoracic). This is a surgical tool used directly on the patient's body.
- Device Description: The description confirms it's a "wound retraction device providing thoracic and abdominal access and protection from wound contamination." This aligns with a surgical instrument.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside the body to provide information about a patient's health, diagnosis, or condition. IVDs are typically used in laboratories or point-of-care settings for testing biological samples.
Therefore, the Surgisleeve™ Wound Protector is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Surgisleeve™ Wound Protector is indicated for use to access the abdominal cavity during surgery through an atraumatically retracted incision, deliver maximum exposure of the abdominal cavity with minimum incision size, and protect against wound contamination during laparoscopic and open surgery. Additionally, the small size Wound Protector is indicated for use to access the thoracic cavity during cardiac and general surgical procedures through an atraumatically retracted incision. The extra-small Wound Protector is also indicated for use to access the thoracic cavity and other soft tissue retraction during cardiac and general surgical procedures through an atraumatically retracted incision.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, KKX
Device Description
Wound retraction device providing thoracic and abdominal access and protection from wound contamination
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity, thoracic cavity
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)
In-vitro and in-vivo tests were performed to verify that the performance of the Surgisleeve™ Wound Protector with Retraction Ring is substantially equivalent to the predicate devices. To validate that the proposed device performs as intended to provide access into the body cavity and maintain maximum retraction, the following tests were performed:
- In-vitro proximal ring rolling .
- . In-vitro strength of attachment between film and proximal (exterior) and distal (interior) rings
- In-vitro film weld strength .
- In-vitro retraction ring compression ● force
- . In-vivo digital proximal ring insertion
- In-vivo proximal ring rolling
- In-vivo retraction ring insertion and ● removal
- . In-vivo digital distal ring removal
The results of the performance evaluation demonstrate that the Surgisleeve™ Wound Protector extra-large with Retraction ring performed substantially equivalent to the predicate device, Surgisleeve™ Wound Protector K140064.
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.
Surgisleeve™ Wound Protector K140064
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name, "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA," arranged in a circular pattern around the edge. At the center of the seal is a stylized emblem consisting of three human profiles facing to the right, stacked on top of each other, representing the department's focus on health and human well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 26, 2014
Covidien LLC Mr. Michael Koczocik Product Specialist, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473
Re: K143091
Trade/Device Name: Surgisleeve " Wound Protector Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ, KKX Dated: October 27, 2014 Received: October 28, 2014
Dear Mr. Koczocik:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
1
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.
for
Sincerely yours,
David-Krause -S
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
5. Indications for Use
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
|-------------------------------------------------------------------------|--|---------------------------------------------------------------------------------------------------|
| Indications for Use | | |
| 510(k) Number (if known) | | |
| K143091 | | |
| Device Name | | |
Surgisleeve™ Wound Protector
Indications for Use (Describe)
The Surgisleeve™ Wound Protector is indicated for use to access the abdominal cavity during surgery through an atraumatically retracted incision, deliver maximum exposure of the abdominal cavity with minimum incision size, and protect against wound contamination during laparoscopic and open surgery. Additionally, the small size Wound Protector is indicated for use to access the thoracic cavity during cardiac and general surgical procedures through an atraumatically retracted incision. The extra-small Wound Protector is also indicated for use to access the thoracic cavity and other soft tissue retraction during cardiac and general surgical procedures through an atraumatically retracted incision.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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Image /page/3/Picture/0 description: The image shows the logo for Covidien. The logo consists of a blue square with a white square inside, followed by the word "COVIDIEN" in blue. The word "COVIDIEN" is in a sans-serif font and is slightly larger than the square logo.
510(k) Summary
This 510(k) summary of data used to demonstrate substantial equivalence is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR క్తి807.98
| NAME: | COVIDIEN |
|---|---|
| ADDRESS: | 60 Middletown Avenue |
| North Haven, Connecticut 06473 USA | |
| CONTACT PERSON: | Michael Koczocik |
| Product Specialist, Regulatory Affairs | |
| PHONE NUMBER: | (203) 492-6312 |
| FAX NUMBER: | (203) 492-5029 |
| DATE PREPARRED: | October 27, 2014 |
| TRADE/PROPRIETARY NAME: | Surgisleeve™ |
| COMMON/USUAL NAME: | Wound Protector |
| CLASSIFICATION NAME: | Endoscope and Accessories per 21 CFR § |
| 876.1500 | |
| Surgical Drape and Drape Accessories per 21 | |
| CFR § 878.4370 | |
| PRODUCT CODE: | GCJ, KKX |
| CLASSIFICATION PANEL NAME: | Gastroenterology and Urology |
| General and Plastic Surgery, | |
| FDA PANEL NUMBER: | 78, 79 |
| DEVICE CLASS: | Pursuant to 21 CFR § 876.1500 and 21 CFR § |
| 878.4370 an endoscope and | |
| accessories/surgical drape is a Class II device | |
| PREDICATE DEVICE(S): | Surgisleeve™ Wound Protector K140064 |
| DEVICE DESCRIPTION: | Wound retraction device providing thoracic and |
| abdominal access and protection from wound | |
| contamination |
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Image /page/4/Picture/0 description: The image contains the logo for Covidien. The logo consists of a blue square with a white cross in the center, followed by the word "COVIDIEN" in blue, sans-serif font. The square is positioned to the left of the word.
INTENDED USE:
The Surgisleeve™ Wound Protector is indicated for use to access the abdominal cavity during surgery through an atraumatically retracted incision, deliver maximum exposure of the abdominal cavity with minimum incision size, and protect against wound contamination during laparoscopic and open surgery. Additionally, the small size Wound Protector is indicated for use to access the thoracic cavity during cardiac and general surgical procedures through an atraumatically retracted incision. The extra-small Wound Protector is also indicated for use to access the thoracic cavity and other soft tissue retraction during cardiac and general surgical procedures through an atraumatically retracted incision.
SUMMARY COMPARING THE TECHNOLOGICAL CHARACTERISTICS OF THE PROPOSED AND PREDICATE DEVICE(S)
Cylindrical Film is designed to retract an incision and provide protection from wound contamination. The interior and exterior rings are flexible to aid insertion, film retraction, and removal. The technological characteristics of the extra-large Surgisleeve™ remain the same as the 510(k) cleared Surgisleeve™ device (K140014). The retraction ring of the large and extra-large Surgisleeve™ Wound Protector is a rigid circular ring accessory that attaches to the exterior ring that aids in maintaining maximum retraction for both the large and extra-large device when necessary
The Surgisleeve™ Wound Protector's
MATERIALS:
All components of the Surgisleeve™ Wound Protector are comprised of materials which are in accordance with ISO 10993-1
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Image /page/5/Picture/0 description: The image shows the Covidien logo. The logo consists of a blue square with a white square inside, and the word "COVIDIEN" in blue text to the right of the square. The logo is simple and modern, and the colors are clean and professional.
PERFORMANCE DATA:
In-vitro and in-vivo tests were performed to verify that the performance of the Surgisleeve™ Wound Protector with Retraction Ring is substantially equivalent to the predicate devices. To validate that the proposed device performs as intended to provide access into the body cavity and maintain maximum retraction, the following tests were performed:
- In-vitro proximal ring rolling .
- . In-vitro strength of attachment between film and proximal (exterior) and distal (interior) rings
- In-vitro film weld strength .
- In-vitro retraction ring compression ● force
- . In-vivo digital proximal ring insertion
- In-vivo proximal ring rolling
- In-vivo retraction ring insertion and ● removal
- . In-vivo digital distal ring removal
CONCLUSION:
The results of the performance evaluation demonstrate that the Surgisleeve™ Wound Protector extra-large with Retraction ring performed substantially equivalent to the predicate device, Surgisleeve™ Wound Protector K140064.