(38 days)
The Axiom Fascial Closure Device is used in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
A single-use medical device used to close laparoscopic trocar site defects. Closure of laparoscopic trocar site defects is used to reduce the risk of herniation which results in adverse effects to the patient and costly surgical revision by the healthcare provider. The Axiom Fascial Closure System provides mechanical assistance to assure reliable suture placement during fascial closure procedures.
The Axiom Fascial Closure System is a single-use medical device designed to close laparoscopic trocar site defects by providing mechanical assistance for reliable suture placement. The provided documents highlight that the device's approval through a 510(k) premarket notification is based on its substantial equivalence to predicate devices, namely the Covidien EndoClose and the Cooper Surgical Carter-Thomason CloseSure System. Rather than a clinical study with specific acceptance criteria and performance metrics typically associated with AI/software devices, the safety and effectiveness of the AXIOM Fascial Closure System were demonstrated through device qualification testing comparing it to these predicate devices.
Here's the breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Functional Equivalence to Predicate Devices) | Reported Device Performance |
|---|---|
| Structural Integrity: Device must withstand loading conditions. | Demonstrated structural integrity when subjected to loading. |
| Penetration Force: Forces required to penetrate a bench model with the suture passer for suture placement must be acceptable. | Demonstrated acceptable forces required to penetrate the bench model with the suture passer for placement of suture. |
| Biocompatibility: Materials used in construction must be biocompatible. | Demonstrated biocompatibility of materials used. |
| Suture Placement Acceptability: Ability to achieve acceptable suture placement in a bench model. | Study demonstrated acceptability of suture placement in the bench model. |
| Substantial Equivalence: With regard to indications for use, general technological characteristics, principle of operation, and materials, the new device must be substantially equivalent to predicate devices. | The Axiom Fascial Closure System is substantially equivalent to the Covidien EndoClose and the Cooper Surgical Carter-Thomason CloseSure System. |
2. Sample size used for the test set and the data provenance
The provided text only refers to "bench models" for testing. There is no specific sample size or data provenance (country of origin, retrospective/prospective) mentioned as this was likely bench testing, not human or animal studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not mentioned in the provided text. The testing appears to be primarily engineering and materials-based, not involving expert interpretation of "ground truth" as would be relevant for diagnostic AI devices.
4. Adjudication method for the test set
This information is not mentioned in the provided text. Adjudication methods are typically relevant for studies involving human interpretation or subjective outcomes, which is not the nature of the described tests.
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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive technologies, not for a mechanical fascial closure device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This device is a mechanical tool, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.
7. The type of ground truth used
The "ground truth" in this context is the successful demonstration of:
- Structural integrity (engineering standard)
- Appropriate penetration forces (biomechanical standard)
- Biocompatibility (materials science standard)
- Acceptable suture placement (functional performance standard in a bench model).
This is based on objective measurements against engineering and performance specifications, not on expert consensus, pathology, or outcomes data in the typical sense for diagnostic devices.
8. The sample size for the training set
Not Applicable. The Axiom Fascial Closure System is a mechanical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data for model development.
9. How the ground truth for the training set was established
Not Applicable, as there is no training set for a mechanical device.
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Axiom Technology Partners - Fascial Closure Device 510k
DEC 300 2019 3. Premarket Notification 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
Submitter Information:
Axiom Technology Partners, LLC.
1351 Third Street, Suite 301
Santa Monica, CA 90401
Date Summary Prepared: November 5, 2010
Contact Person:
James Dreher, Manager
Telephone: 424.744.8773
Fax: 424 744 8774
Device Name:
Trade Name(s): Axiom Fascial Closure System
Classification Name: Laparoscope, General and Plastic Surgery
Panel: General and Plastic Surgery
Product Code: GCJ
Device Description:
A single-use medical device used to close laparoscopic trocar site defects. Closure of laparoscopic trocar site defects is used to reduce the risk of herniation which results in adverse effects to the patient and costly surgical revision by the healthcare provider. The Axiom Fascial Closure System provides mechanical assistance to assure reliable suture placement during fascial closure procedures.
Indications for Use:
The Axiom Fascial Closure Device is used in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
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Predicate Device Information:
This device is substantially equivalent to the Covidien EndoClose and the Cooper Surgical Carter-Thomason CloseSure System.
Comparison to Predicate Device(s):
The Axiom Fascial Closure System is substantially equivalent with regard to indications for use, general technological characteristics, principle of operation, and materials.
Summary of Performance Testing
The new device is technologically similar to the predicate device. Device qualification testing has demonstrated:
- . Structural integrity of the Axiom Fascial Closure System when subjected to loading
- t Forces required to penetrate the bench model with the suture passer for placement of suture
- . Biocompatibility of materials used in the construction of the Axiom Fascial Closure System
- . Study demonstrating acceptability of suture placement in the bench model
Conclusions
The Axiom Fascial Closure System is substantially equivalent to the Covidien EndoClose and the Cooper Surgical Carter-Thomason CloseSure System.
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, with its wings forming a human figure. The eagle is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Axiom Technology Partners, LLC % Quality Management Consulting Mr. Richard Rush 2939Alhambra Drive Belmont, California 94002
DEC 3 0 2010
Re: K103412
Trade/Device Name: Axiom Fascial Closure System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCW, GCJ, HCF Dated: November 16, 2010 Received: November 22, 2010
Dear Mr. Rush:
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
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Page 2 - Mr. Richard Rush
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/CDRH/CDRHOffices/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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Pettine Deo. Oscipr
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEC 3 0 2010
Indications for Use
KI03412 510(k) Number (if known):
Device Name: Axiom Fascial Closure System
Indications For Use
510(k) Number (if known):
The Axiom Fascial Closure Device has application in laparoscopic procedures for approximation of tissues and percutaneous suturing for - - incision sites.
Closing
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krehel MKM
(Division Sign-Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K103412
§ 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.