(61 days)
Not Found
No
The summary describes a mechanical wound retraction device and makes no mention of AI or ML.
No
The device is described as a wound retraction device used to access body cavities during surgery and protect against wound contamination, which are surgical and protective functions, not therapeutic ones.
No
The device, Surgisleeve™ Wound Protector, is described as a wound retraction device that provides access and protection during surgery. Its intended uses are to access body cavities and protect against wound contamination, which are functions related to surgical assistance rather than diagnosis.
No
The device description and performance studies clearly indicate a physical wound retraction device, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used during surgery to access and protect surgical incisions. This is a surgical tool, not a device used to examine specimens in vitro (outside the body) to provide diagnostic information.
- Device Description: The description confirms it's a "Wound retraction device providing abdominal access and Protection from wound contamination." This aligns with a surgical tool.
- Performance Studies: The performance studies focus on the physical properties and in-vivo use of the device during surgery (insertion, instrument use, specimen removal), not on diagnostic accuracy or analysis of biological samples.
IVD devices are used to examine specimens such as blood, urine, or tissue to diagnose diseases or conditions. The Surgisleeve™ Wound Protector does not perform this function.
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 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 testing to support the intended use of this device includes:
- Film Penetration Resistance .
- Strength of Attachment Between Film and Proximal Ring, Distal . Ring
- Film Weld Seam Strength .
- . In-Vivo Use:
- . Ring Insertion and Rolling,
- Instrument Insertion and Removal, .
- . Specimen removal,
- . Thoracic use,
- . Thoracic use specimen removal,
- . Digital ring removal
The results of the performance evaluation demonstrate that the Surgisleeve™ Wound Protector (subject device) performed substantially equivalent to the predicate devices, the Alexis™ wound retractor (K041711) and the Covidien Surgisleeve™ wound protector (K120061).
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
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
0
.
Surgisleeve™ Wound Protector XS
| K140064 | |
|---|---|
| --------- | -- |
510(k) Summary
| SUBMITTER: | Covidien
60 Middletown Avenue
North Haven, CT 06473 USA
Tel. No.: (203) 492-5000 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Michael Koczocik
Product Specialist, Regulatory Affairs
Phone: (203) 492-6312
Fax: (203) 492-5029 |
| DATE PREPARED: | January 2014 |
| TRADE/PROPRIETARY NAME: | Surgisleeve™ Wound Protector |
| Product Code(s) | GCJ
KKX |
| 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 |
| PREDICATE DEVICE(S): | Applied Medical, Alexis™ Wound Retractors (K041711),
Covidien Surgisleeve™ Wound Protector (K120061) |
| DEVICE DESCRIPTION: | Wound retraction device providing abdominal access and
Protection from wound contamination |
| 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. |
| TECHNOLOGICAL
CHARACTERISTICS | The Surgisleeve™ Wound Protector 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. |
| MATERIALS: | The Surgisleeve™ Wound Protector is comprised of materials that
have been evaluated in accordance with ISO 10993-1:2009, Biological
Evaluation of medical devices - Part 1: Evaluation and Testing. |
1
Surgisleeve™ Wound Protector XS
PERFORMANCE DATA:
In-vitro and in-vivo testing to support the intended use of this device includes:
- Film Penetration Resistance .
- Strength of Attachment Between Film and Proximal Ring, Distal . Ring
- Film Weld Seam Strength .
- . In-Vivo Use:
- . Ring Insertion and Rolling,
- Instrument Insertion and Removal, .
- . Specimen removal,
- . Thoracic use,
- . Thoracic use specimen removal,
- . Digital ring removal
CONCLUSION:
The results of the performance evaluation demonstrate that the Surgisleeve™ Wound Protector (subject device) performed substantially equivalent to the predicate devices, the Alexis™ wound retractor (K041711) and the Covidien Surgisleeve™ wound protector (K120061).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 12, 2014
Covidien Mr. Michael Koczocik Product Specialist, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473
Re: K140064
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: January 10, 2014 Received: January 10, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
Image /page/2/Picture/11 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" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three flowing lines representing the body and arms.
3
Page 2 - Mr. Michael Koczocik
forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aquel
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Surgisleeve™ Wound Protector XS
Indications for Use
510(k) Number (if known): K140064
Device Name: Surgisleeve™ Wound Protector
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.
Prescription Use X (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)
Long H. Che checong H. Ch A 000300 100 1 1 = 1 3003690
for BSA
(Division Sign-Off) Division of Surgical devices 510(k) Number: K140064