(96 days)
The Applied Alexis Wound 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.
The smaller two sizes of Alexis are also intended to be used to: - Scal off the incision opening to permit insufflating the peritoneum.
- Convert the incision wound to an additional trocar port site.
The Applied Wound Retractor consists of a flexible polymer membrane formed into the shape of a cylinder. Attached to each open end of the cylinder are two semi-rigid polymer rings. The rings are molded in a plastic material. The Wound Retractor package also includes an incision template. The device will be manufactured in four sizes, small, medium-large and large. The small and medium products will have an iris valve feature that allows the wound protector to be adjusted from fully open to fully closed. This capability allows Alexis to seal the incision area or to seal around a trocar.
The provided 510(k) summary for the Alexis™ Wound Retractor describes a medical device and its substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria from an AI/algorithm performance perspective.
This document is for a physical medical device (a surgical wound retractor), not a software or AI-powered device. Therefore, the questions related to AI/algorithm performance, such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this submission.
Instead, the submission focuses on the biological safety, material properties, and functional performance of the physical device, and its sterilization process, demonstrating substantial equivalence to a predicate device.
Here's an analysis of the provided text based on the questions, acknowledging that the focus is on a physical medical device:
Analysis of the Provided Information
1. A table of acceptance criteria and the reported device performance
The document doesn't present a formal table of acceptance criteria with numerical performance metrics as would be expected for an AI/algorithm. However, it does state that the device underwent specific tests and "passed" or "complied" with relevant standards:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Was found non-toxic and non-irritant when tested in accordance with ISO 10993, Part I: Biological Evaluation of Medical Devices. |
| Material Tensile Strength | Materials tested in accordance with applicable standards and was determined to pass tensile strength (ASTM D 412). |
| Material Elongation | Materials tested in accordance with applicable standards and was determined to pass elongation (ASTM D 412). |
| Material Tear Strength | Materials tested in accordance with applicable standards and was determined to pass Tear Strength (ASTM D 624). |
| Functional Performance | Functional performance testing has been completed and has passed the required testing. |
| Sterility Assurance Level | Sterilization using 100% EO provides a sterility assurance level of 10⁻⁶. |
| Sterilant Residue Levels | Will be in compliance with ANSI/AAMI/ISO 10993-7:1995 for limited exposure devices (≤ 20 mg ethylene oxide, ≤ 12 mg ethylene chlorohydrin). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the device is a physical surgical retractor, not a software or AI-powered diagnostic/analytic tool that processes data from a test set. The "testing" referred to is for material and functional properties, not data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable for the same reasons as above. "Ground truth" in the context of this device would refer to the successful operation of the device in a clinical setting, which is inferred from its design and material testing, not from expert review of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of data, which is not part of the submission for a physical device like this.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. An MRMC study is used for evaluating diagnostic performance (often of imaging devices or AI algorithms). This device is a surgical tool, not a diagnostic one, and does not involve "human readers" or AI assistance in decision-making.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This question refers to the performance of an algorithm without human intervention, which is irrelevant for a physical surgical retractor.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As it's a physical device, the "ground truth" for its performance is assessed through physical and chemical testing standards, not clinical pathology or outcomes data in the sense of a diagnostic device. The "ground truth" that the device effectively retracts and protects wounds is supported by its design and material properties, and its substantial equivalence to a predicate device that is already cleared for such functions.
8. The sample size for the training set
This is not applicable as there is no AI algorithm being trained.
9. How the ground truth for the training set was established
This is not applicable as there is no AI algorithm being trained.
In summary: The provided text details the regulatory submission for a physical medical device (a wound retractor). The "acceptance criteria" and "studies" mentioned relate to the device's material properties, biocompatibility, sterilization, and functional design, ensuring it meets safety and effectiveness standards, primarily through conformance to established ISO and ASTM standards and demonstrated substantial equivalence to a legally marketed predicate device. The questions posed are primarily relevant to AI/software as a medical device submissions.
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510(k) SUMMARY
| 510(k) NUMBER: | K031889 |
|---|---|
| SUBMITTED BY: | Applied Medical Resources Corporation22872 Avenida EmpresaRancho Santa Margarita, CA-92688(949) 713-8000 |
| CONTACT PERSON: | Mary Jo StegwellVice President of Regulatory Affairs and Clinical Programs |
| DATE OF PREPARATION: | September 12, 2003 |
| NAME OF DEVICE: | Wound Retractor |
| CLASSIFICATION NAME: | Drape, Surgical, General & Plastic Surgery.(Regulation Number 21CFR 878.4370, Surgical drape anddrape accessories). |
| TRADE NAME: | AlexisTM Wound Retractors |
| PREDICATE DEVICE: | Dexterity Protractor (Protector Retractor and ProtectorRetractor with drape, K954824), Medical CreativeTechnologies, Inc. Colmar, PA. |
| DESCRIPTION | The Applied Wound Retractor consists of a flexiblepolymer membrane formed into the shape of a cylinder.Attached to each open end of the cylinder are two semi-rigid polymer rings. |
SUMMARY STATEMENT: The Applied Alexis Wound Retractor is indicated for use in retracting and protecting an abdominal incision during laparoscopic or open surgery. It is intended to allow the surgeon to access the abdominal cavity through an atraumatically retracted wound that provides maximum exposure with minimum incision size. Further, once positioned in the abdominal wall, the Alexis Wound Retractor is intended to protect against wound contamination. To perform these functions, Alexis Wound Retractors are constructed as a cylindrical membrane sheath that has two rings attached to each open end. The rings are molded in a plastic material. The Wound Retractor package also includes an incision template.
The device will be manufactured in four sizes, small, medium-large and large. The small and medium products will have two additional indications. These models have an iris valve feature that allows the wound protector to be adjusted from fully open to fully closed. This capability allows Alexis to seal the incision area or to seal around a trocar. The procedure may
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then be returned to fully laparoscopic and an additional trocar may be placed through the incision site.
The Wound Retractor is simple to set up and easy to use. A sterile skin marker is used to mark an incision line at the surgery site and the incision is made. The Wound Protecting sheath is placed in position through the incision with one ring inside the abdomen. The external ring is placed in traction and folded over itself until it contacts the abdomen. Once securely in place, the Alexis Wound Retractor keeps the incision open during the procedure. The wound protective sheath lines the incision and protects it from contamination and injury from instruments during the procedure.
The Alexis Wound Retractor has been found non-toxic and non-irritant when tested in accordance with ISO 10993, Part I: Biological Evaluation of Medical Devices. The materials used in the manufacturing of the Alexis Wound Retractor have been tested in accordance with applicable standards and was determined to pass tensile strength, elongation. (ASTM D 412) and Tear Strength (ASTM D 624). Functional performance testing has been completed and has passed the required testing.
The Applied Wound Retractor is a disposable, single-use device and is packaged inside a Tyvek/Mylar peel pouch, which is standard packaging material for Applied's products. The packaged product is then placed in an outer product shelf pack.
The Applied Wound Retractor is sterilized using 100% EO. Applied's 100% EO sterilization cycle provides a sterility assurance level of 106. Sterilization for Applied Medical's EO cycle uses three half-cycle validation runs, which incorporate biological indicators and temperature monitors distributed throughout the load to verify gas penetration and profile temperature distribution. Spore strip biological indicators of B. subtillis var. niger with a population of 10° are used to monitor routine finished product sterilization loads. Sterilant residue levels will be in compliance with ANSI/AAMI/ISO 10993-7:1995 for limited exposure devices which is 20 mg ethylene oxide and 12 mg ethylene chlorohydrin.
The Alexis Wound Retractor is substantially equivalent to predicate devices in design methodology, principle of operation and clinical utility. The device introduces no new safety or effectiveness issues when used as instructed.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird, represented by three curved lines that suggest wings and a body. The logo is black and white.
Public Health Service
SEP 2 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mary J. Stegwell Vice President of Regulatory Affairs and Clinical Programs Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, California 92688
Re: K031889
Trade/Device Name: Alexis™ Wound Retractors Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: June 13, 2003 Received: July 1, 2003
Dear Ms. Stegwell:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Ms. Stegwell
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); good manufacturing practice requirements as set 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.
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runne
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Applied Medical Resources is providing this separate cover page for the Alexis Wound Retractor's "Indications for Use" as required.
510(k) Number:
K03/886
Alexis Wound Retractor Device Name:
Indications for Use: The Applied Alexis Wound 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.
The smaller two sizes of Alexis are also intended to be used to:
- · Scal off the incision opening to permit insufflating the peritoneum.
- · Convert the incision wound to an additional trocar port site.
Suzer Kums
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K031889
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR Over-The -Counter Use ----------
(Optional Format 1-2-96)
§ 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.