(462 days)
No
The device description and intended use are purely mechanical in nature, focusing on physical retraction and protection. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No
The device is a surgical retractor used for access and wound protection, not for treating a disease or condition.
No
The device is a surgical retractor used to access and protect the abdominal cavity during surgery. It does not perform any diagnostic functions or analyze medical data to provide a diagnosis.
No
The device description clearly states it is a disposable single-use surgical device made of physical components (protector/retractors) and includes information about sizes, materials (Tyvek pouch, carton), and packaging, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Applied Wound Protector/Retractor is a surgical device used to physically retract and protect wound margins during surgery. It does not analyze or process biological specimens.
- Intended Use: The intended use clearly describes its function in accessing and protecting the abdominal cavity during surgery, not in analyzing samples.
The device is a surgical instrument used in vivo (within the living body) during a surgical procedure, not in vitro (in glass or outside the body) for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Applied Wound Protector/Retractor 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.
- Protect against wound contamination during laparoscopic and open surgery.
Product codes
KKX
Device Description
Applied Medical's Alexis O wound protector/retractors are disposable single-use surgical devices used to establish access to internal body cavities and spaces. The protector/retractors are designed for soft tissue retraction and provide 360 degrees of a circumferential retraction and 360 degrees of protection of the wound margins. The predicate Alexis devices are made in sizes ranging from Small to XLarge that accommodate incisions ranging from 2.5 to 17cm. This submission request clearance for adding an XXL and XXXL sizes to the product family. The XXL is for incisions ranging from 17 to 25cm; the XXXL is for incisions ranging from 25 to 30cm.
The protector/retractors have a shelf life of three years and are delivered with a template that is used to determine the incision length for the corresponding retractor chosen for the procedure. Protector/retractors are packaged in a Tyvek pouch placed inside a carton.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal 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)
DISCUSSION OF NONCLINICAL TESTS SUBMITTED: There are no FDA recognized standards that specify performance of wound protectors/retractors. For that reason. Applied Medical created non-clinical test protocols specifically designed to confirm substantial equivalence of the proposed device relative to the predicate device. In addition, the Alexis sheath was exposed to a microbial challenge per ANSI AAMI PN70: 2003/R 2009. "Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities." This standard determines a barrier classification level for protection against blood borne pathogens.
Testing included:
- Visual inspection to verify mechanical integrity of the device. .
- Reliability (cvcling) testing to verify the device can complete five activations . without losing structural integrity.
- Wound retraction testing in simulated and in porcine tissue to verify the device . retracts straight incisions into circular openings.
- Biocompatibility testing per ISO10993 (cytotoxicity, sensitization and irritation) to ● verify the device materials did not elicit a tissue response.
- Microbial performance testing per ANSI AAMI PN70: 2003/R 2009 to verify the . device met the requirements of a level 4 surgical gown as defined by test method ASTM F1671, "Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood Borne Pathogens using Phi-X174 Bacteriophage Penetration as a Test System."
DISCUSSION OF CLINICAL TESTS SUBMITTED: No clinical testing was performed on the subject devices. However, the following study, offered as supporting material, was performed using the predicate devices of K031889:
- . Reid K .. et al. Barrier wound protection Decreases Surgical Site Infection in Open Elective Colorectal Surgery: A Randomized Clinical Trial. Dis Colon Rectum. 2010 Oct: 53(10); 1374-1380
This randomized clinical trial compared the use of the Alexis wound retractor with standard retraction in open elective colorectal resectional surgery. One hundred thirty consecutive patients. 18 years and older. were randomly assigned to have either wound retraction/protection with Alexis (n=64) or standard wound retraction (n=66). Randomization was performed after the patient was anesthetized. The primary end point was the incidence of superficial or deep surgical site infection occurring within 30 days of the procedure as defined by the Centers for Disease Control and Prevention. The secondary end point was performance (effectiveness) of the Alexis wound protectors as assessed by participating surgeons.
The results revealed a clinically significant reduction in SSI in the trial population subjected to the Alexis device. SSI rate with Alexis was 4.7%, without, 22.7%. Seventy eight percent of the SSI events were diagnosed after discharge from the hospital and there was no difference in rates of reoperation, readmission or formal wound drainage between the two groups. There were no adverse effects or complications reported as a result of the Alexis device in any surgeries using the Alexis device. Seven of the 8 surgeons (78%) in the trial are adapting Alexis as part of their standard setup.
CONCLUSIONS DRAWN FROM TESTING: Applied Medical's testing demonstrated that the subject device is safe and effective, and performs as well as the predicate device of K031889.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SSI rate with Alexis was 4.7%, without, 22.7%.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) SUMMARY
Frans VandenBroek
January 25, 2013
Wound protector/retractor
fvandenbroek@appliedmedical.com
FEB 0 8 2013
Applied Medical Resources Corporation 510(k) OWNERS NAME: 22872 Avenida Empresa Rancho Santa Margarita, CA-92688 (949) 713-8000 (949) 713-8205 (FAX)
CONTACT PERSON:
DATE OF PREPARATION:
TRADE NAME:
Alexis® O Wound Protector/retractor models C8405 and C8406
COMMON NAME:
CLASSIFICATION NAME:
Surgical drape and drape accessory, General & Plastic Surgery. Class II, 21CFR §878.4370, Product Code KKX
PREDICATE DEVICE:
Applied Medical Alexis Wound Retractor (K031889)
DEVICE DESCRIPTION: Applied Medical's Alexis O wound protector/retractors are disposable single-use surgical devices used to establish access to internal body cavities and spaces. The protector/retractors are designed for soft tissue retraction and provide 360 degrees of a circumferential retraction and 360 degrees of protection of the wound margins. The predicate Alexis devices are made in sizes ranging from Small to XLarge that accommodate incisions ranging from 2.5 to 17cm. This submission request clearance for adding an XXL and XXXL sizes to the product family. The XXL is for incisions ranging from 17 to 25cm; the XXXL is for incisions ranging from 25 to 30cm.
The protector/retractors have a shelf life of three years and are delivered with a template that is used to determine the incision length for the corresponding retractor chosen for the procedure. Protector/retractors are packaged in a Tyvek pouch placed inside a carton.
INTENDED USE: The Applied Medical Alexis wound protector/retractor models C8405 and C8406 have the same intended use as the predicate devices: accessing the abdominal cavity during surgery through an atraumatically retracted incision. The protector/retractors deliver maximum exposure of the abdominal cavity with minimum incision size and protect against wound contamination during laparoscopic and open surgery.
1
SUMMÀRY OF TECHNOLOGICAL CHARACTERISTICS: The Alexis O Wound protector/retractor has the same technological characteristics as the predicate devices of K031889. Predicate and proposed device are identical in design, principle of action and clinical utility. Both consist of a clear flexible membrane formed into a cylindrical sleeve with two semi-rigid polymer rings at each end. Alexis is placed by advancing one of the rings through an incision in the abdominal wall. The ring establishes the sheath's internal anchor.
The second ring remains outside the body and is placed in traction and repeatedly rolled over itself with the thumbs until the ring contacts the abdominal wall. The tension in the sheath retracts the abdominal tissue and the incision becomes a circular opening. Alexis allows access to the peritoneum while protecting the incised tissue from contamination and injury throughout the procedure.
DISCUSSION OF NONCLINICAL TESTS SUBMITTED: There are no FDA recognized standards that specify performance of wound protectors/retractors. For that reason. Applied Medical created non-clinical test protocols specifically designed to confirm substantial equivalence of the proposed device relative to the predicate device. In addition, the Alexis sheath was exposed to a microbial challenge per ANSI AAMI PN70: 2003/R 2009. "Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities." This standard determines a barrier classification level for protection against blood borne pathogens.
Testing included:
- Visual inspection to verify mechanical integrity of the device. .
- Reliability (cvcling) testing to verify the device can complete five activations . without losing structural integrity.
- Wound retraction testing in simulated and in porcine tissue to verify the device . retracts straight incisions into circular openings.
- Biocompatibility testing per ISO10993 (cytotoxicity, sensitization and irritation) to ● verify the device materials did not elicit a tissue response.
- Microbial performance testing per ANSI AAMI PN70: 2003/R 2009 to verify the . device met the requirements of a level 4 surgical gown as defined by test method ASTM F1671, "Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood Borne Pathogens using Phi-X174 Bacteriophage Penetration as a Test System."
DISCUSSION OF CLINICAL TESTS SUBMITTED:
No clinical testing was performed on the subject devices. However, the following study, offered as supporting material, was performed using the predicate devices of K031889:
- . Reid K .. et al. Barrier wound protection Decreases Surgical Site Infection in Open Elective Colorectal Surgery: A Randomized Clinical Trial. Dis Colon Rectum. 2010 Oct: 53(10); 1374-1380
2
This randomized clinical trial compared the use of the Alexis wound retractor with standard retraction in open elective colorectal resectional surgery. One hundred thirty consecutive patients. 18 years and older. were randomly assigned to have either wound retraction/protection with Alexis (n=64) or standard wound retraction (n=66). Randomization was performed after the patient was anesthetized. The primary end point was the incidence of superficial or deep surgical site infection occurring within 30 days of the procedure as defined by the Centers for Disease Control and Prevention. The secondary end point was performance (effectiveness) of the Alexis wound protectors as assessed by participating surgeons.
The results revealed a clinically significant reduction in SSI in the trial population subjected to the Alexis device. SSI rate with Alexis was 4.7%, without, 22.7%. Seventy eight percent of the SSI events were diagnosed after discharge from the hospital and there was no difference in rates of reoperation, readmission or formal wound drainage between the two groups. There were no adverse effects or complications reported as a result of the Alexis device in any surgeries using the Alexis device. Seven of the 8 surgeons (78%) in the trial are adapting Alexis as part of their standard setup.
CONCLUSIONS DRAWN FROM TESTING: Applied Medical's testing demonstrated that the subject device is safe and effective, and performs as well as the predicate device of K031889.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 8, 2013
Mr. Frans Vandenbroek Principal Regulatory Specialist Applied Medical Resources Corporation 22872 Avenida Empresa RANCHO SANTA MARGARITA CA 92688
Re: K113268
Trade/Device Name: Alexis O Wound Protector/Retractors, models C8405 and C8406 Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: January 28, 2013 Received: January 30, 2013
Dear Mr. Vandenbroek:
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. Ilsting 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.
4
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 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/CDRH0ffices/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 vours.
hori
Theti
Starshfield.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K113268
Device Name: Alexis O Wound Protector/Retractors, models C8405 and C8406
Indication for use: The Applied Wound Protector/Retractor 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. ●
- Protect against wound contamination during laparoscopic and open surgery. .
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
Elizabeth F. Clayerie 2013.02.07 17:05:51 -05'00' (Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Antool, Dental Devices 3268 510(k) Number: