ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP

K130059 · Ibi Israel Biomedical Innovations , Ltd. · PBQ · Jul 29, 2013 · Obstetrics/Gynecology

Device Facts

• Record ID: K130059
• Device Name: ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP
• Applicant: Ibi Israel Biomedical Innovations , Ltd.
• Product Code: PBQ · Obstetrics/Gynecology
• Decision Date: Jul 29, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The EndoFast Reliant™ SCP is indicated for fixation of surgical mesh to tissue for tissue reinforcement during a laparoscopic Sacrocolpopexy approach. The EndoFast Reliant™ LAP is indicated for fixation of surgical prosthetic material to tissues for tissue reinforcement during a laparoscopic Sacrocolpopexy approach.

Device Story

EndoFast Reliant SCP and LAP are sterile, single-use systems for laparoscopic sacrocolpopexy. Systems consist of metal fixation devices preloaded with metal spider fasteners, a plastic handle, and (for SCP) a monofilament polypropylene surgical mesh. Devices are introduced via 5mm trocar. During surgery, physician attaches mesh to vaginal vault and promontorium using fasteners to restore anatomical position of uterus and cervix. Fasteners provide mechanical fixation of prosthetic material to tissue. Benefits include minimally invasive approach for pelvic organ prolapse repair. Output is physical fixation of mesh to tissue; no electronic output or clinical decision support provided.

Clinical Evidence

No clinical data provided. Evidence consists of non-clinical bench testing: functional characteristics, cyclic load endurance, fastener deployment reliability, pull-out force, handle reliability, and cadaver studies. Biocompatibility evaluated per ISO 10993-1 and FDA G95-1. Sterilization validated for Gamma and EtO processes. MR compatibility assessed.

Technological Characteristics

System components: metal fixation devices, metal spider fasteners, plastic handle, monofilament polypropylene mesh (8x20cm). Mechanical fixation principle. Dimensions and shape optimized for 5mm trocar laparoscopic access. Sterilization: Gamma (instruments) and EtO (mesh). Biocompatibility per ISO 10993-1. MR compatible.

Indications for Use

Indicated for fixation of surgical mesh or prosthetic material to tissue for reinforcement during laparoscopic sacrocolpopexy procedures in patients requiring pelvic organ prolapse repair.

Regulatory Classification

Identification

An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes. (2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant. (3) An umbilical clamp is an instrument used to compress the umbilical cord. (4) A uterine curette is an instrument used to scrape and remove material from the uterus. (5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix. (6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus. (7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination. (8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix. (9) A gynecological cerclage needle is a looplike instrument used to suture the cervix. (10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus. (11) A gynecological fibroid screw is an instrument used to hold onto a fibroid. (12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity. (13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina. (14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures. (15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus. (16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis. (17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina. (18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.

Special Controls

*Classification.* (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.

Predicate Devices

• EndoFast Reliant™ System (K080836)
• Autosuture™ TACKER (K090470)

Submission Summary (Full Text)

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JUL 2 9 2013

# 510(K) SUMMARY

[as required by section 807.92(c)]

# EndoFast Reliant™ SCP and EndoFast Reliant™ LAP

510(k) Number K__

## Applicant's Name:

Israel Biomedical Innovations Ltd. 2 Ha-Eshel St. P.O.BOX 3081 Caesarea Industrial Park 38900, Israel Tel.: [phone], Ext. 202 Fax: [phone]

Contact Person:

Elissa Burg VP Quality Assurance and Regulatory Affairs Telephone: [phone] ext. 107 Mobile: [phone] Fax: [phone] E-mail: [e-mail]

#### Prepared On:

January 7, 2013 .

#### Trade Name:

EndoFast Reliant™ SCP EndoFast Reliant™ LAP

*SCP = Sacrocolpopexy *LAP = Laparoscopic

Classification:

Name: Fixation, non-absorbable or absorbable, for pelvic use Product Code: PBQ Regulation No: 884.4530 Class: 2 Classification Panel: Obstetrics/Gynecology

Name: Mesh, Surgical, Polymeric

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Image /page/1/Picture/1 description: The image contains a logo with the text "Israel Biomedical Innovations" on the left and the letters "IBI" in large, bold font on the right. Above the text is a circular graphic composed of four curved shapes, each partially filled in black, arranged to suggest a rotating or interconnected design. The overall impression is a corporate logo for a biomedical company based in Israel.

Name: Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed. Product Code: OTO Regulation No: 878.3300 Class: 2 Classification Panel: Obstetrics/Gynecology

#### Predicate Devices:

EndoFast Reliant™ System-K080836 Autosuture™ TACKER - K090470

### Device Description:

The EndoFast Reliant™ SCP (Sacrocolpopexy) is a sterile, single use system which consists of the following parts:

- 3 metal Fixation Devices; each preloaded with a spider fastener composed of . metal and includes the MRI Safety Information that is stated in the labeling.
- . Plastic Handle; connects to the Fixation Device.
- . Surgical mesh composed of monofilament polypropylene material; cut in a rectangular shape of 8x20cm.

The device is introduced through a 5mm trocar in a laparoscopic approach. The mesh is attached to the vaginal vault and the vagina is pulled towards the posterior pelvic bony part. The other end of the mesh is attached to the promontorium, using two fixation points, to restore the normal anatomical position of the uterus and cervix.

The EndoFast Reliant™ LAP (Laparoscopic) is a sterile, single use system which consists of the following parts:

- 3 metal Fixation Devices, each preloaded with a spider fastener composed of . metal and include the MRI Safety Information that is stated in the labeling.
- Plastic Handle; connects to the Fixation Device. .

The fasteners are introduced through a 5mm trocar in laparoscopic procedures.

#### Intended Use:

The EndoFast Reliant™ SCP is indicated for fixation of surgical mesh to tissue for tissue reinforcement during a laparoscopic Sacrocolpopexy approach.

The EndoFast Reliant™ LAP is indicated for fixation of surgical prosthetic material to tissues for tissue reinforcement during a laparoscopic Sacrocolpopexy approach.

#### Technological Characteristics:

The technological Characteristics of the EndoFast Reliant™ SCP and EndoFast The tochlorogreat charges of the EndoFast Reliant™ System cleared under K080836. The dimensions of the spider fasteners and fixation device in the EndoFast

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Image /page/2/Picture/1 description: The image shows the logo for Israel Biomedical Innovations (IBI). The logo consists of two parts: a circular symbol at the top and the company name below. The circular symbol is made up of four curved shapes arranged in a circle, with alternating black and white colors. The text "Israel Biomedical Innovations" is written in a smaller font size to the left of the letters "IBI", which are written in a larger, bold font.

Reliant™ SCP and EndoFast Reliant™ LAP have been decreased to accommodate a laparoscopic approach to be used in Sacrocolpopexy procedures. In addition, the shape of the fixation device in the EndoFast Reliant TSCP and EndoFast Reliant™ LAP has been changed to accommodate a laparoscopic approach to be used in Sacrocolpopex y procedures.

### Performance Testing:

The appropriate tests to determine substantial equivalence were completed. These include testing in accordance with Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (March 22, 1999) and tests designed by the company to address substantial equivalence.

- 1. The following non-clinical tests have been performed: Performance Tests:
- a) Functional Characteristics Test to demonstrate appropriate functionality characteristics of EndoFast Reliant SCP after sterilization, Vibration and Drop test and a shelf life study.
- b) EndoFast Reliant SCP Fastener Support Endurance to Cyclic Loads to validate the endurance of the SCP Spider Fastener in supporting the cyclic load on the surgical mesh.
- c) SCP Fastener Deployment Reliability and Pull-Out Force Test to verify the deployment reliability and pullout force required for fastener failure, and to verify that the surgical mesh and the artificial tissue have no influence/ effect on the deployment of the Fastener of the SCP Fixation Device
- d) SCP Fixation Device and Handle Reliability and Force Test to verify the reliability of the SCP Fixation Device and the Handle that is attached to it in deploying the Fasteners without fault and to test the force applied during the deployment.
- e) Two cadaver studies were performed utilizing the EndoFast Reliant™ SCP.
- f) Comparative pull-out tests were conducted in order to assess the new products' equivalency with predicate devices.
- 2. Gamma Sterilization Validation for the Surgical Instruments Using a Radiation dose of 25 kGy in order to assure products' SAL 10°
- 3. EtO Sterilization Validation for the Sujrgical Mesh Using Overkill Approach in order to assure products' SAL 106.
- 4. Shelf Life Tests Using accelerating aging in order to assure the products' adequate performances during their shelf life.
- 5. Biocompatibility The products' were evaluated with accordance to ISO 10993-1 and FDA Blue Book Memorandum, G95-1.
- 6. MR compatibility -- In order to assure the safe use of the device at MRI environment.

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Image /page/3/Picture/1 description: The image contains a logo with the letters "IBI" in bold, black font on the right side. To the left of the letters, there is text that reads "Israel Biomedical Innovations" in a smaller, less bold font. Above the text and letters, there is a circular graphic with four abstract shapes arranged in a clockwise direction.

# Conclusion:

Israel Biomedical Innovations Ltd. believes that, based on the information provided in this submission, the EndoFast Reliant™ SCP and the EndoFast Reliant™ LAP are
substantially equivalent to their predicate devices without raising any new safety and/or effectiveness issue.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.

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

#### July 29, 2013

IBI Israel Biomedical Innovations Ltd. % Elissa Burg VP Quality Assurance and Regulatory Affairs 2 Ha-Eshel Street, P.O. Box 3081 CAESAREA INDUSTRIAL PARK 38900 ISRAEL

K130059 Re:

> Trade/Device Name: EndoFast Reliant™ SCP, Endo Fast Reliant™ LAP Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: Class II Product Code: PBQ, OTO Dated: June 10, 2013 Received: June 17, 2013

Dear Elissa Burg,

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

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Page 2 - Elissa Burg

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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 [phone] or [phone] or at its Internet address http://www.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/6/Picture/0 description: The image shows a logo with the letters "IBI" in large, bold font on the right side. To the left of the letters, there is smaller text that reads "Israel Biomedical Innovations." Above the text and letters, there is a circular graphic composed of four curved shapes arranged in a clockwise direction. The logo appears to be for a company or organization related to biomedical innovations in Israel.

#### INDICATIONS FOR USE STATEMENT

K130059 510(k) Number (if known): __

EndoFast Reliant™ SCP Device Name: * SCP = Sacrocolpopexy

#### Indications for Use:

The EndoFast Reliant™ SCP is indicated for fixation of surgical mesh to tissue for tissue reinforcement during a laparoscopic Sacrocolpopexy approach.

Prescription Use _ X (Per 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (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)

# Benjamin R. Fish 2013.07.29 16:29:29

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K130059 510(k) Number

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Image /page/7/Picture/0 description: The image shows a logo with the letters IBI in bold, black font on the right side. To the left of the letters is the text "Israel Biomedical Innovations" in a smaller, less bold font. Above the text and letters is a circular symbol that appears to be made of four curved arrows pointing inward.

## INDICATIONS FOR USE STATEMENT

K130059 510(k) Number (if known):_

EndoFast Reliant™ LAP Device Name: * LAP = Laparascopic

Indications for Use:

The EndoFast Reliant™ LAP is indicated for fixation of surgical prosthetic material to tissues for tissue reinforcement during a laparoscopic Sacrocolpopexy approach.

Prescription Use _ X (Per 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (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)

Benjamin R. Fisher 2013.07 29 16:30:20 -04'00'

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K130059 510(k) Number