The Freedom Inguinal Hernia Implant is used to plug or patch a hernia opening. The implant is wholly manufactured from polypropylene. It is comprised of two polypropylene meshes and two small polypropylene rings. A multi looped shaped core fills the hernia opening while an underlay patch reinforces the defect and holds the implant in place. This underlay patch helps to prevent expulsion and rotation. Once the tissue defect is prepared, the implant is deployed into the defect area using the delivery device provided in the Freedom Inguinal Hernia Repair kit. The delivery device serves to compact the implant and provide access to the defect opening to aid implantation. Once deployed, the tissue contracts around the implant, gripping it in place. There are two different sizes of implants and corresponding delivery devices to accommodate different size defects. The implant and delivery device are provided sterile for single patient use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Freedom Inguinal Hernia Implant." This document primarily focuses on establishing "substantial equivalence" to predicate devices rather than deeply detailing acceptance criteria of a standalone study for an AI/algorithm-based device.

However, I can extract information related to the device performance and acceptance criteria implied by the studies conducted to demonstrate its safety and effectiveness for substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a structured table of "acceptance criteria" and "reported device performance" in the way one would for an AI algorithm's metrics (e.g., sensitivity, specificity, AUC). Instead, it describes general desired outcomes for a hernia implant. Based on the objectives of the clinical studies, here's an attempt to structure the information:

Acceptance Criteria (Implied from Study Objectives)	Reported Device Performance (as per clinical studies)
Primary Efficacy Objectives
Procedural success (ability to deploy implant)	- Successfully deployed in proper location (Cadaver studies)- "Safe and effective for the treatment of inguinal hernias" (Group 1, n=61)- No reports of unresolved post-operative complications (Group 1, n=61)
Freedom from hernia recurrence (1, 6, 12, 24, 36 months)	- No recurrences after 3 years (Group 1, n=61)- No long term complications or recurrences (Amato Study, n=30, mean 25.23 months follow-up)- No recurrences (Petrella/Venditti Study, n=24, mean 4.5 months follow-up)
Secondary Complications Objectives
No perioperative/postoperative complications (1, 6, 12, 24, 36 months)	- No reports of unresolved perioperative complications (Group 2, n=30)- No reports of tissue injury or spermatic cord complications (Group 2, n=30)- No long term complications (Amato Study, n=30)
No bleeding, swelling, hematoma from dilation/delivery	- No reports of tissue tearing injury or spermatic cord injury (n=78 total with dilation technique)
No seroma, infection/abscess, testicular/spermatic cord injury, wound complications, symptomatic pain, or chronic pain syndrome	- No reports of spermatic cord injury or compression complications due to device rotation/sizing (Group 2, n=27, 1 year+ follow-up)- No chronic discomfort (Amato Study, n=30)
Biocompatibility	Complies with requirements for device classification (Pre-Clinical Tests)
In vitro Performance	Meets pre-determined acceptance criteria or specifications (Pre-Clinical Tests)
In vivo Performance	Validated implantation procedure, demonstrated tissue incorporation (Pre-Clinical Tests)
Delivery Device Performance	Successfully deployed implant in proper location (Cadaver studies), validated implantation technique (Cadaver studies)

2. Sample Size Used for the Test Set and Data Provenance

The document describes several clinical experiences and studies, rather than a single "test set" for an algorithm. It uses data from patient groups as clinical evidence for substantial equivalence.

Group 1 (Retrospective Data):
- Sample Size: n=61 patients
- Data Provenance: Single center, single surgeon clinical experience. Likely unknown specific country, but general clinical practice data. Retrospective (patients followed for a minimum of 3 years after implantation with custom implants).
Group 2 (Prospective/Retrospective Mixed):
- Sample Size: n=30 patients (received Insightra manufactured implant). 27 followed for a year or more.
- Data Provenance: Unspecified country, but clinical experience with Insightra's device. Follow-up ranged from perioperative to one year post-implantation, with a mean of 25 months for those followed longer. This suggests a prospective collection for at least part of the follow-up, but the initial collection might have been retrospective to some degree.
Amato Study (Prospective):
- Sample Size: n=30 patients (total implants n=34 due to bilateral hernias)
- Data Provenance: Single center, single investigator. Country not specified. Prospective study enrollment June 2009 to August 2011.
Petrella/Venditti Study (Prospective):
- Sample Size: n=24 enrolled patients (target enrollment = 80)
- Data Provenance: Single center, two investigators. Country not specified. Prospective study enrollment Dec 2011 to present (at time of filing).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

For these clinical studies involving surgical implants, the "ground truth" is typically established by the implanting surgeon(s) and following clinicians who assess patient outcomes (recurrence, complications, comfort).

Group 1: Single implanting surgeon (qualifications not specified beyond "surgeon").
Group 2: Unspecified number of clinicians involved, likely the surgeons performing the implantations and follow-ups.
Amato Study: 1 investigator (likely implanting surgeon). Qualifications not specified.
Petrella/Venditti Study: 2 investigators (likely implanting surgeons). Qualifications not specified.

There is no mention of "experts" in the context of independent review or adjudication of study endpoints, as might be done for imaging-based diagnostic devices.

4. Adjudication Method for the Test Set

There is no explicit mention of an adjudication method (like 2+1, 3+1) for the clinical outcomes in any of the studies. The outcomes were likely recorded by the treating physicians/investigators. For surgical outcomes like hernia recurrence or complications, direct clinical examination and patient reporting, sometimes supplemented by imaging, serve as the basis for recorded outcomes.

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 performed. This document describes a medical device (hernia implant), not an AI algorithm for diagnosis or interpretation that would involve "human readers."

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

No, this document describes an implanted medical device, not an algorithm. Therefore, the concept of "standalone performance" for an algorithm is not applicable.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the effectiveness and safety of the hernia implant primarily relies on:

Clinical Outcomes Data: Direct observation of procedural success, absence of recurrence or complications, patient-reported symptoms (pain, discomfort), and clinician assessment of tissue injury, seroma, infection, etc.
Pathology/Histology (Implied): The in vivo survival study demonstrated "tissue incorporation," which would typically involve histological examination of explanted tissue.
Imaging Data (Limited): Ultrasound findings were mentioned for a subset of patients in the Amato study ("Full and stable obliteration of twelve patients examined at 3, 6 and 12 months.") but not for the Petrella/Venditti study.

8. The Sample Size for the Training Set

This document does not describe an AI/ML algorithm, so there is no "training set." The "development" of the device involved:

In vitro and In vivo (animal) tests: For material properties, mechanical performance, and biocompatibility.
Cadaver studies: To validate implantation procedure and technique.
Early clinical experience: The Group 1 patients (n=61) received "custom implants fabricated by the implanting surgeon," which can be seen as preceding the Insightra manufactured implant, providing early clinical insights that might conceptually relate to "training" in an operational sense, but not algorithmic.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" in the context of an AI algorithm, this question is not applicable. For the pre-clinical and early clinical development of the device, "ground truth" was established through standard laboratory testing, animal studies (pathology, tissue incorporation), and clinical follow-up by surgeons/investigators.

Summary

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11 3557

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5 510(k) Summary

a. Submitter

AUG 2 3 2012

Applicant Name:

Insightra Medical 9200 Irvine Center Drive, Suite 200 Irvine, CA 92618

Contact Person: Wayne Noda Date Summary Prepare: Revised August 22, 2012

b. Device Information

Trade Name: Freedom Inquinal Hernia Implant Common Name: Surgical mesh Classification Name: Surgical polymeric mesh (21 CFR 878.3300) Product Code: FTL

c. Predicate Devices

Bard Perfix Plug (K922916) Ethicon Prolene Hernia System (K984220)

d. Device Description

e. Indications for Use:

The Freedom Inguinal Hernia Implant is intended to reinforce soft tissues where weakness for open repair of inquinal hernias exists.

Technological Characteristics and Comparison to Predicate Devices f.

The Freedom Inguinal Hernia Implant is of similar design and materials commonly used in other marketed hernia repair meshes.

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Table 1 provides a comparison of the Freedom Inguinal Hernia Implant with the predicate hernia repair implants. This table illustrates the substantial equivalence of the subject device with the predicates.

	Freedom Inguinal HerniaImplant	Ethicon Prolene HerniaSystem	Bard Perfix Plug
510(k) Clearance	This submission	K984220	K922916
Indications for Use	The Freedom InguinalHernia Implant is intendedto be implanted to reinforcesoft tissues whereweakness for open repair ofinguinal hernias exists.	The PROLENE HerniaSystem is indicated forthe repair of abdominalwall hernia defects	This product isindicated for therepair of groinhernia defects
Shape	Image: Freedom Inguinal Hernia Implant Shape	Image: Ethicon Prolene Hernia System Shape	Image: Bard Perfix Plug Shape
Texture	Mesh	Mesh	Mesh
Material	Polypropylene	Polypropylene	Polypropylene
Configuration	Underlay mesh patch,looped shaped mesh core	Underlay mesh patch,cylindrical mesh core,Onlay mesh patch	Conical multi layermesh core, Onlaymesh patch
How is the implantsecured?	Inserted into the hernia; nosutures necessary	Inserted into the hernia;no sutures necessary	Inserted into thehernia; no suturesnecessary
Number of models	2	6	4
Size range (smallest tolargest)	25 mm core & 60 mm dia.underlay patch40 mm core & 70 mm dia.Underlay patch	Onlay patch - 44mm x100mm to 55mm x125mmCore Connector (for allsizes) -19mm dia x 13mmheightUnderlay patch-75mmto 100mm diameter	25 x 34 mm to41 x 50 mm;preshaped onlaypatch same for allsize plugs
Sterilization	EtO	EtO	EtO

Table 1 – Comparison Table for Freedom Inguinal Hernia Implant

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g. Pre-Clinical Test Results:

In vitro, in vivo and biocompatibility tests were performed on the Freedom Inguinal Hernia Implant. The in vitro tests showed that the device meets pre-determined acceptance criteria or specifications that were based on the clinical demands placed on the device. The in vivo testing validated the implantation procedure and a survival study was performed that demonstrated the tissue incorporation of the implant. Results of the in vivo study were published in the journal of Artificial Organ (3). The biocompatibility testing showed the Freedom Inquinal Hernia Implant complies with the requirements for this device classification.

Cadaver studies were performed during the development of both the Freedom Inguinal Hernia Implant as well as the delivery device. These studies showed that the implant could be successfully deployed in the proper location and further validated the implantation technique. These results were considered in the final design configurations.

h. Results of Clinical Experience:

Two groups of data from relevant clinical experience were collected and reviewed. The first group of patients (n=61) received custom implants that were fabricated from surgical polypropylene mesh by the implanting surgeon. This was a single center, single surgeon clinical experience. In these patients, the surgeon used both stainless steel and rigid plastic tubes to provide the slight dilation of the defect and access required to deliver the implant. Patients were followed for a minimum of 3 years after the date of implantation. One patient was lost to follow up due to unrelated heart failure death after 14 months. The results demonstrated that defect dilation with tubes and treatment with flower shaped implants was safe and effective for the treatment of inguinal hernias. After 3 years, there have been no reports of unresolved post operative complications, recurrences, or chronic discomfort in these patients. The diameters of the dilation tubes were the diameters of the Insightra Medical Delivery Device, that is subject of this premarket notification.

The second group of patients reviewed (n=30) received the Insightra manufactured implant that is the subject of this submission. The implant was delivered using standard open surgical techniques using a previous version of the Freedom Inquinal Hernia Delivery System. This delivery system was identical dimensionally to the delivery system that is included in this premarket notification. Follow-up ranged from perioperative to one year post-implantation. Of these 30 patients, 27 were followed for a year or more with a mean followup of 25 months (ranging 11 to 36 months). There were no reports of unresolved perioperative complications, tissue injury or spermatic cord complications associated with this device.

In exceptional cases, an additional flat polypropylene mesh has been deployed to cover the inquinal floor, over the Freedom Inquinal implant that obliterates the hernia opening. This further reinforces the inguinal canal at the hernial protrusion when the groin structures appear obviously weak. The onlay flat mesh is not sutured or fixed to the inguinal structures, instead only connected to the central core of the Freedom Inguinal implant with a single polypropylene suture. Previous experiences of using this procedural variant produced, with the exception of some very seldom reported discomfort during the early postoperative stage, no unusual symptoms reported by patients who received the onlay patch in addition to the Freedom Inguinal implant.

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For all patients in both groups reviewed with at least one year followup (n= 78) who received this dilation delivery technique, there were no reports of tissue tearing injury or spermatic cord injury. There have been no reports of dislodgements, unresolved post operative complications, chronic discomfort or recurrence of hernia. For the twenty seven patients in the second group who were followed for a year or more and received the Insightra Medical manufactured implant, there were no reports of spermatic cord injury or compression complications due to device rotation or inappropriate sizing.

The second study group by Amato (n=30) is summarized along with a third independent investigator sponsored study by Petrella, in the device labeling. Descriptive tables are included in the device "Technique Guide" as follows;

These clinical studies followed cohorts of patients (total n=54) that met the following inclusion/exclusion criteria:

Inclusion Criteria:	Exclusion Criteria:
• Scheduled to undergo routine inguinalhernia repair • Competent to give consent • Clinically relevant inguinal hernia(classification: NYHUS I, II, IIIa, IIIb) • Male or female • Over 18 years old to 85 years old • Life expectancy of at least 12-months • Diagnosed with direct, indirect or mixedinguinal hernia, unilateral or bilateral • Primary or recurrent hernia	• Signs of obvious local or systemicinfection • Hernia was not in the inguinal area • Presenting with unstable angina orNYHA class of IV • Pregnant • Active drug user • Immunosuppression, prednisone>15mg/day, active chemotherapy • End stage renal disease • Abdominal ascites • Skin infection in area of surgical field • BMI > 35

Both studies used the following objectives:

Primary Efficacy Objectives	Secondary ComplicationsObjectives
• Procedural success is defined as the abilityto successfully deploy the implant into theinguinal hernia defect• Freedom from hernia recurrence at the timepoints of 1, 6, 12, 24, 36 months	• Collection of data on anyperioperative/postoperativecomplications (1, 6, 12, 24, 36months)• Bleeding, swelling or hematomafrom hernia defect dilation orimproper delivery or implantationtechnique• Seroma, infection/abscess, testicularor spermatic cord injury in males,wound complications, symptomaticpain or chronic pain syndrome.

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	Prospective study of a single operatorcase series of a modified plugtechnique and new 3D hernia implant
Amato Study
Number of centers/investigators	1 center/ 1 investigators
Study Enrollment Period	June 2009 to August 2011
Number of patients	30
Number of implants*	25mm: n=12 40mm: n=22*Four cases were double unilateralhernias
Patient demographics	Male = 30/Female = 0
	BMI (Kg/m2) = 28.4 (21.7 – 34.9)
	Age = 50.23 mean, range 23-82
	Hernia types: Indirect=17, Direct=13
	Hernia size: Mean 32 mm (range 20 –37.7)
	Hernia type:
	NYHUS Type 1 = 5
	NYHUS Type 2 = 13
	NYHUS Type 3a = 12
	NYHUS Type 3b = 4
	Anesthesia: Local = 63%Spinal = 17%General = 20%
Operative procedure specifics	Procedure duration: Mean 29 minutes(range 22 – 38)
	Defect measurement: Intra operativemeasurement of the dissected flacciddefect using surgical scale for implantsizing

Patient Follow up Outcomes/adverseevents	Follow up: Mean = 25.23 months (range11.0-36.5)
	Outcomes/Adverse: no long termcomplications or recurrences at this time
	In two exceptional cases, an additional flatpolypropylene mesh was deployed to cover theinguinal floor, over the Freedom Inguinalimplant that obliterated the hernia opening.This further reinforced the inguinal canal at thehernial protrusion when the groin structuresappeared obviously weak.
Additional Outcomes – Two patients in thiscohort received onlay mesh patches	Patient #1 – Male, 82 yrs, Double unilateralhernia – Rt Indirect, Rt Direct, 25mm and40mm implants used, Nyhus 2 & 3a. BMI: 29.Comorbidities: Myocardial ischemic disease,hypertension. Non recurrent hernias. Followup = 18.2 mos.
	Patient #2 – Male, 75 yrs, Lf Mixed hernia,40mm implant, Nyhus 3b. BMI: 26.Comorbidities: BPCO, myocardialinsufficiency, hypertension. Non recurrenthernia. Follow up = 18.2
	Results of these two procedures to date havehad no complications or unusual symptoms.
	Patient #1 reported occasional discomfort
	during the early postoperative stage but selfresolved after 5 months post op.
Ultrasound findings in cohort of patients	Full and stable obliteration of twelvepatients examined at 3, 6 and 12 months.

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Petrella/Venditti Study	Prospective single arm study of theProFlor Inguinal hernia Device
Number of centers/investigators	1 center/ 2 investigators
Study Enrollment Period	Dec 2011 to present
Number of patients	24 enrolled; Target enrollment = 80
Number of implants	25mm: n=5 40mm: n=19
Patient demographics	Male = 22/Female = 2$BMI (Kg/m^2) = 25.2 (19,4 - 35,2)$Age = 52.3 mean, range (31 - 73)Hernia types: Indirect=20, Direct=4Hernia size: 15mm40mmNYHUS Type 2 = 20NYHUS Type 3a = 4
Operative procedure specifics	Local anesthesiaProcedure duration: 24 min mean, (20-30)Defect measurement: Intra operativemeasurement of the dissected flacciddefect using surgical scale for implantsizing
Patient Follow up Outcomes/adverseevents	Follow up: Mean = 4.5 months (range 3.0-6.0)Outcomes/Adverse: None observed
Ultrasound findings in cohort of patients	Ultrasound scans were not a requirementof the study and were not performed forthis cohort

510(k) Summary Conclusion: i.

In summary, the Insightra Freedom Inquinal Hernia Implant path through the 510(k) requlatory analysis is as follows:

The Insightra Freedom Inquinal Hernia Implant and the Bard Perfix Plug and Ethicon Prolene Hernia System predicate devices, are all intended for use in the repair of inguinal hernia defects.
The Insightra Freedom Inguinal Hernia Implant has similar key technological . characteristics as the Bard Perfix Plug and Ethicon Prolene Hernia System devices. All three are manufactured from polypropylene mesh, all use mesh patch reinforcements, and all are inserted into the hernia defect without the need for suture;
Although the Insightra Freedom Inguinal Hernia Implant and predicate devices have a . minor technological difference in terms of the method of delivery, this difference does not raise any new types of safety or effectiveness questions. In addition, valid scientific methods exist for assessing the effects of the differences in delivery methods. Preclinical and clinical data demonstrate that these devices are substantially equivalent.

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Therefore, the Insightra Freedom Inguinal Hernia Implant meets the criteria for substantial equivalence to the Bard Perfix Plug and Ethicon Prolene Hernia System predicate devices.

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Image /page/7/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 overlapping wing segments, representing health, services, and people. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Insightra Medical % Mr. Wayne Noda Chief Technology Officer 9200 Irvine Center Drive, Suite 200 Irvine, California 92618

AUG 2 3 2012

Re: K113552

Trade/Device Name: Freedom Inguinal Hernia Implant Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: August 20, 2012 Received: August 21, 2012

Dear Mr. Noda:

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 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

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Page 2 - Mr. Wayne Noda

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.

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/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 yours.

Sincerely, yours,

Erin S. Keith

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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Indications for Use

510(k) Number (K113552):

Device Name: Freedom Inguinal Hernia Implant

Indications for Use:

The Freedom Inguinal Hernia Implant is intended to be implanted to reinforce soft tissues where weakness for open repair of inguinal hernias exists.

Prescription Use _ × AND/OR Over-The-Counter Use _ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krane for MM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113552

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.