The PARIEFIX Endoscopic Stapler is indicated for approximation of soft tissues and fixation of surgical mesh to tissues during laparoscopic surgical procedures such as hernia repair.

Device Description

The PARIEFIX device is an Endoscopic Stapler composed of a disposable delivery instrument and resorbable fixation devices. The PARIEFIX Delivery Instrument consists of an ergonomic handle, trigger, locking/unlocking mechanism, rotation knob, shaft containing ten fixation devices, and retractable hollow needle. The trigger, locking/unlocking mechanism, rotation knob, and hollow needle all function in the delivery of the fixation device to the tissue. A visual marker at the distal tip of the shaft indicates the position of the retractable needle to aid in placement of the fixation device. The resorbable fixation device consists of a connection pin, which connects the distal anchoring tip to the proximal tip. The distal anchoring tip penetrates the biological tissues and, after back and forth motion, is anchored into the tissues. The proximal tip anchors the mesh to the biological tissues.

AI/ML Overview

The provided text describes the Sofradim Production PARIEFIX™ Endoscopic Stapler. However, it does not contain detailed information about specific acceptance criteria, reported device performance metrics in a quantitative manner, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The relevant section, "PERFORMANCE TESTING 7.", states:
"Testing was performed to determine the performance characteristics of the PARIEFIX Resorbable Fixation Devices in comparison with the predicate devices. The test results showed that the Sofradim and predicate devices were similar in performance characteristics."

This statement confirms that performance testing was done and that the device was found to be "similar" to predicate devices. However, it lacks the specific quantitative data needed to fill out the requested table and answer many of the subsequent questions.

Therefore, many of the requested fields cannot be populated from the provided text.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified quantitatively in the provided text. The general criterion appears to be "similar performance characteristics" to predicate devices.	The device's performance characteristics were "similar" to the predicate devices (Ethicon Endopath® EMS and Origin Tacker® system). No specific metrics or quantitative values are provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not specified.
Data provenance: Not specified (e.g., country of origin, retrospective/prospective).

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 information is not applicable as the performance testing described is for a physical medical device (endoscopic stapler) and not for an AI/diagnostic algorithm where expert-established ground truth would typically be required. The "ground truth" here would relate to mechanical performance, not diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for the type of device and testing described.

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 for a physical surgical device, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable; this is for a physical surgical device, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this type of device would likely be based on engineering specifications, mechanical testing standards, and possibly in-vitro or ex-vivo performance metrics comparing staple strength, deployment reliability, material biocompatibility, and similar physical properties. The document states "Testing was performed to determine the performance characteristics," implying engineering and mechanical tests.

8. The sample size for the training set

Not applicable for this type of device; this is not an AI/machine learning product.

9. How the ground truth for the training set was established

Not applicable for this type of device; there is no training set in the context of AI/machine learning.

Summary

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OCT 22 2003

K032093 page 1/2

510(k) Summary For the Sofradim Production PARIEFIX ™ Endoscopic Stapler

1. SPONSOR/MANUFACTURER

Sofradim Production 116 avenue du Formans 01600 Trevoux France

Contact: Christophe Cosson 33 (0)4 74 08 90 00 Telephone: Facsimile: 33 (0)4 74 08 90 02

2. DEVICE NAME

PARIEFIX™ Proprietary Name: Endoscopic stapler/Laparoscopic accessory Common/Usual Name: Classification Name: Endoscope and/or accessories

3. PREDICATE DEVICES

Ethicon Endopath® EMS K913469 Origin Tacker® System K944415 Phusis® Absorbable Interference Screw K970879 [same PLA material]

DEVICE DESCRIPTION 4.

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K032093 page 2/2

penetrates the biological tissues and, after back and forth motion, is anchored into the tissues. The proximal tip anchors the mesh to the biological tissues.

INTENDED USE ડ.

The PARIEFIX Endoscopic Stapler is indicated for approximation of soft tissues and fixation of surgical mesh to tissues during laparoscopic surgical procedures such as hernia repair.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The PARIEFIX Resorbable Fixation Device material is identical to that described in K970879 for the cleared Phusis® Absorbable Interference Screw.

The PARIEFIX device is substantially equivalent to the Ethicon Endopath® EMS and the Origin Tacker® system. The PARIEFIX device, the Ethicon Endopath® EMS, and the Origin Tacker® system have the same intended use in that they are all used for surgical mesh fixation via laparoscopic approach. All of the devices consist of a disposable endoscopic stapler delivering ten or more implantable fixation devices.

PERFORMANCE TESTING 7.

Testing was performed to determine the performance characteristics of the PARIEFIX Resorbable Fixation Devices in comparison with the predicate devices. The test results showed that the Sofradim and predicate devices were similar in performance characteristics.

July 3, 2003

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes extending from its head, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

OCT 2 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sofradim Production c/o Ms. Mary McNamara-Cullinane, RAC Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Re: K032093

Trade/Device Name: Sofradim PARIEFIX Endoscopic Stapler Regulation Number: 21 CFR 876.1500, 21 CFR 878.4750 Regulation Name: Endoscope and/or accessories, Implantable staples Regulatory Class: II Product Code: GCJ, GDW Dated: July 3, 2003 Received: July 28, 2003

Dear Ms. McNamara-Cullinane:

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.

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 (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.

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Page 2 - Ms. Mary McNamara-Cullinane, RAC

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) 594-4659. 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,

Mark N Milliken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K032093

510(k) Number (if known):

Device Name: Sofradim PARIEFIX Endoscopic Stapler

Indications for Use:

The PARIEFIX Endoscopic Stapler is indicated for approximation of soft tissues and fixation of surgical mesh to tissues during laparoscopic surgical procedures such as hernia repair.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Millhurn
Division Sign Off

on Sign-Off) ivision General, Restorative and Neurological Devices

510(k) Number K032093

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

July 3, 2003

Regulation Number and Section

§ 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.