(64 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:
- Seal off the incision opening to permit insufflating the peritoneum.
- Convert the incision wound to an additional trocar port site.
- Access the thoracic cavity or other soft tissue retraction during cardiac and general surgical through an atraumatically-retracted incision.
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 device will be manufactured in five sizes, extra-small, small, medium, medium-large and large. The extra-small, 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 then be returned to fully laparoscopic and an additional trocar may be placed through the incision site. The Wound Retractor package also includes an incision template. The Applied Wound Retractor is a disposable, single-use device and is packaged inside a Tyvek/Mylar peel pouch.
This 510(k) summary for the Alexis™ Wound Retractors does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria in the format you've outlined for performance studies of AI/diagnostic devices.
Instead, this document describes a traditional medical device (wound retractor), and its clearance process is based on substantial equivalence to a predicate device, rather than a performance study with defined sensitivity/specificity metrics.
Here's a breakdown of what is provided and why it doesn't fit your requested format:
What's in the document that relates to device evaluation (though not in your requested format):
- Biological Evaluation: "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." This is a pass/fail criterion for biocompatibility, not a performance metric like sensitivity or AUC.
- Material Testing: "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)." These are material property tests, again with pass/fail criteria.
- Functional Performance Testing: "Functional performance testing has been completed and has passed the required testing." This is a very general statement, indicating the device performs its intended functions (retraction, protection). The specific acceptance criteria and results are not detailed here.
- Sterilization Validation: "Applied's 100% EO sterilization cycle provides a sterility assurance level of 10⁻⁶." This is a specific performance metric for sterility.
Why this document doesn't provide the requested information for an AI/diagnostic device performance study:
- Nature of the Device: The Alexis™ Wound Retractor is a physical surgical tool, not an AI algorithm or a diagnostic test that generates quantitative results (like a score or a classification) requiring metrics such as sensitivity, specificity, or AUC.
- Regulatory Pathway: This device was cleared through the 510(k) pathway based on substantial equivalence to a predicate device (Heartport Soft Tissue Retractor). This means the FDA determined it is as safe and effective as a legally marketed device, circumventing the need for extensive clinical trials or complex performance studies generally associated with novel diagnostics or AI. The argument is that it "introduces no new safety or effectiveness issues."
- Lack of AI/Diagnostic Metrics: The document doesn't discuss "ground truth," "expert consensus," "sample sizes for test/training sets," "MRMC studies," or "standalone performance" because these concepts are not applicable to the physical wound retractor's clearance.
Attempting to map the available information to your requested structure, acknowledging its limitations:
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Non-toxic and non-irritant (as per ISO 10993, Part I) | "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." |
| Material Strength | Pass tensile strength, elongation (ASTM D 412), and Tear Strength (ASTM D 624) | "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 | Device performs intended functions (e.g., retraction, protection, sealing, trocar conversion) | "Functional performance testing has been completed and has passed the required testing." (Specific criteria and detailed results are not provided in this summary.) |
| Sterility | Sterility Assurance Level (SAL) of 10⁻⁶ | "Applied's 100% EO sterilization cycle 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 which is 20 mg ethylene oxide and 12 mg ethylene chlorohydrin." (Implied compliance is the performance here). |
2. Sample size used for the test set and the data provenance:
- This is not applicable as it's not a diagnostic/AI study. Testing for biological evaluation, material properties, and functional performance would have involved a sufficient number of device samples or components according to the respective standards, but a "test set" in the context of image data or patient outcomes is not relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" to be established by experts in this context. Rather, compliance with engineering and biological standards is assessed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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:
- Not applicable. This is not an AI/diagnostic device. The clearance is based on substantial equivalence to a predicate device, implying similar effectiveness without a comparative clinical study in this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" for this device's safety and effectiveness is compliance with recognized standards (ISO, ASTM) and demonstrated equivalence to a predicate device's established safety and effectiveness.
8. The sample size for the training set:
- Not applicable.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided document describes the regulatory clearance of a conventional medical device via the 510(k) pathway, focusing on substantial equivalence and compliance with established engineering and biocompatibility standards, rather than performance metrics typically associated with AI or diagnostic evaluations.
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AUG 2 6 2004
510(k) SUMMAR Y
| 510(k) NUMBER: | PENDING |
|---|---|
| SUBMITTED BY: | Applied Medical Resources Corporation22872 Avenida EmpresaRancho Santa Margarita, CA-92688(949) 713-8000 |
| CONTACT PERSON: | Cheryl BlakeVice President, Regulatory Affairs and Quality Systems |
| DATE OF PREPARATION: | June 18, 2004 |
| NAME OF DEVICE: | Wound Retractor |
| CLASSIFICATION NAME: | Drape, Surgical, General & Plastic Surgery.(Regulation Number 21CFR 878.4370, Surgical drape anddrape accessories). |
| TRADE NAME: | Alexis TM Wound Retractors |
| PREDICATE DEVICE: | Heartport Soft Tissue RetractorCardiovations/ Heartport, Inc.Redwood City, CA |
| 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 incision during laparoscopic or open surgery. It is intended to allow the surgeon to access through an atraumatically retracted wound that provides maximum exposure with minimum incision size. Further, once positioned, 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 cach open end. The rings are molded in a plastic material. The Wound Retractor package also includes an incision template.
Te device will be manufactured in five sizes, extra-small, small, medium, medium-large and large. The extra-small, 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
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to fully closed. This capability allows Alexis to seal the incision area or to seal around a trocar. The procedure may 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 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 10 °. 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or birds in flight, stacked on top of each other.
AUG 2 6 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cheryl Blake Mis. Cheryl Diate
Vice President, Regulatory Affairs and Quality Systems Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, California 92688
Re: K041711
K041711
Trade/Device Name: Alexis Wound Retractor C8312, C8301, C8302, C8303 Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: June 18, 2004 Received: June 23, 2004
Dear Ms. Blake:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your because a reas) to (1) = device is substantially equivalent (for the referenced above and have determined the accosure) to legally marketed predicate devices marketed in indications for use stated in the ensiesary, 1976, the enactment date of the Medical Device interstate commence prior to reay 20, 1978, are cailers and entitled in accordance with the provisions of Amendments, of to devices that have oben frequire approval of a premaintent of the seppered the Federal Food, Drug, and Cosmette 110 (Are, Market the device, subject to the general approval application (1147). Four general controls provisions of the Act include controls provisions of the Fet. "The genting of devices, good manufacturing practice, requirements for animors against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) into controls. Existing major regulations affecting (PMA), it may be subject to such additional controllar controls. Title 21, Parts 800 to 898. In the Coderal your device can be found in the Code of Peacharing your device in the Federal Register.
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Page 2 - Ms. Blake
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA Sissualled of a substantial with other requirements
mean that FDA has made a determination that your device complies with other Federal acception mean that FDA has made a decemmance that your and regulations administered by seciety of of the Act of any rederal statutes and regulations, but not limited to: registration
You must comply with all the Act's requirements, including of sturing mestica You must comply with an the Act 3 requirement 801); good manufacturing practice.
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gEP Bart 800); and i and listing (21 C.FK Fatt 807), laboling (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality systems (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 5 10(k) I his letter will anow you to begin marieting your antial equivalence of your device to a premarket notification. The PDA midness or subsition 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), If you desire specific advice for your device at (301) 594-4618. Also, please note the regulation prease contact the Office of Comphanes and (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miormation on John 2 and Consumer Assistance at its toll-free Division of Sman Manufacturer (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Chiu Lin, Ph.D.
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
er Applied friendications for Use" as required.
510(k) Number:
K04/7//
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:
- · Seal off the incision opening to permit insufflating the peritoneum.
- · Convert the incision wound to an additional trocar port site.
- Access the thoracic cavity or other soft tissue retraction during cardiac and general surgical . Access the though an atraumatically-retracted incision.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The -Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) | ||
| Kein Muley | |||
| (Division Sign-Off) | |||
| Division of Anesthesiology, General Hospital, | |||
| Infection Control, Dental Devices | |||
| 510(k) Number: K041711 |
§ 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.