PERIPATCH SLEEVE, MODELS G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a handwritten alphanumeric string. The string appears to be a combination of letters and numbers, starting with the letter 'K' followed by the numbers '033985'. The handwriting is clear and legible, with each character distinctly formed. The string is written in black ink on a white background. PM DEVICES INC. – PERIPATCH™ SLEEVE 510(K) PREMARKET NOTIF | SECTION 4 | JUN - 4 2004 | 510(k) SUMMARY | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------| | 1. Submitters Name, Address etc.: | PM Devices Inc.<br>2135 – 13700 Mayfield Place<br>Richmond, British Columbia<br>V6V 2E4, CANADA<br>Ph: 604.270-4344 Fx: 604.270-4384<br>www.pmdevices.com<br>Contact: Britta Dombovari<br>Date: December, 2003 | | | 2. Name of Devices: | Trade Name: PeriPatch™ Sleeve1<br>Common Name: Processed bovine pericardial sleeve<br>Classification Name:<br>Mesh, surgical, polymeric –Class II–Product Code: FTM | | Legally marketed devices which PM Devices Inc. claims 3. Predicate Devices: substantial equivalence: | Predicate Device | Manufacture | 510(k) # | Class | |--------------------------------|------------------|----------|-------| | PeriPatch™ Sheet | PM Devices Inc. | K031948 | II | | Glycar Pericardial Patch | Glycar Inc. | K963967 | II | | Supple Peri-Guard® Pericardium | BioVascular Inc. | K983162 | II | | Vascu-Guard | BioVascular Inc. | K942010 | II | | Supple Peri-Guard | BioVascular Inc | K921895 | II | All of the above previously cleared products are composed of processed bovine pericardium and are all used for suture line staple reinforcement. ## 4. Device Description: ## 4a. How the Device Works ## PeriPatch™ Sleeve PeriPatch™ Sleeve consists of one piece of The qlutaraldehyde fixed bovine pericardium that is sutured into a rectanqular shaped tube. A picture can be seen in Figure 2, and an engineering drawing can be found in Appendix C, Engineering Drawings. It is intended for reinforcing surgical staples. These specially prepared sleeves are slipped over the forks of linear or endoscopic surgical staplers. Stapling is carried out according to the stapler manufacture's instructions. The suture is removed and the remaining pericardial tissue is withdrawn with the excised host tissue. The sleeves are intended for a number of resection techniques such as lung volume reductions, biopsies, lobectomies and other soft tissue repairs. Image /page/0/Picture/10 description: The image shows two rectangular objects, possibly bars or blocks, placed diagonally on a dark surface. The objects appear to have a metallic or reflective surface, catching the light and creating highlights. The background is dark and out of focus, which makes the objects stand out. The objects are positioned close to each other, with a slight overlap. Figure 2 - PeriPatch™ Sleeve The available PeriPatch™ Sleeve models and the surgical stapler that they are compatible with are listed in Table 4.1 below. ¹ The PeriPatch™ Sleeve was originally called the StepSaver™ Cylinder, and marketed under that name in Europe (EC) and Canada. The name StepSaver™ Cylinder can be seen in validation reports as it was the name of the device during the validations. The StepSaver™ Cylinder and the PeriPatch™ Sleeve are the same device. 4-1 December, 2003 {1}------------------------------------------------ K070985 ## Table 4.1 Sleeve Sizes | | Endoscopic | | Linear | |---------------|-------------------------|----------------|-------------------------------------------------------------------------------------------------| | Model | Stapler | Model | Stapler | | G35-1, -2, -5 | Auto Suture Endo GIA 30 | 5c6-1, -2, -5 | Auto Suture Endo GIA 60;<br>Ethicon TLC 55 | | E35-1, -2, -5 | Ethicon EZ 35B | 5c8-1, -2, -5 | Auto Suture Endo GIA 80;<br>Ethicon TLC 75 | | G45-1, -2, -5 | Auto Suture Endo GIA 45 | 5c10-1, -2, -5 | Auto Suture Endo GIA 90<br>(re-useable);<br>Auto Suture Endo GIA 90<br>(disposable); 3M ILA 100 | | E45-1, -2, -5 | Ethicon EZ 45B ,EZ 35G | | | | G60-1, -2, -5 | Auto Suture Endo GIA 60 | | | | E60-1, -2, -5 | Ethicon Endopatch 60 | | | # 4b. Scientific Concepts # PeriPatch™ Sleeve The PeriPatch™ Sleeve consists of one piece of glutaraldehyde fixed bovine pericardium that is sutured into a rectangular sleeve. It is intended for reinforcing surgical staples. These specially prepared sleeves are slipped over the forks of linear or endoscopic surgical staplers. Stapling is carried out according to the stapler manufacture's instructions. The suture is removed and the remaining pericardial tissue is withdrawn with the excised host tissue. The PeriPatch™ Sleeve's compatibility with common staplers is similar to predicate devices, see Table 4.2: Table 4.2: Comparison of PeriPatch™ Sleeve sizes available to current predicate devices. | | Endoscopic | | | | Disposable Linear | | | | Reusable<br>Linear | | | | |-------------------------|-------------------|-------------------|-----------------|------------------------|-------------------|-----------|---------|-----------|--------------------|---------|-----------|------------| | | GIA<br>ENDO<br>60 | GIA<br>ENDO<br>30 | ENDOP<br>ATH 60 | ENDOP<br>ATCH<br>EZ 45 | ENDOP<br>ATH 35 | GIA<br>80 | TLC 75 | ILA<br>75 | GIA<br>60 | TLC 55 | GIA<br>90 | ILA<br>100 | | Stapler<br>Manufacturer | USSC | USSC | ETHICON | ETHICON | ETHICON | USSC | ETHICON | 3M | USSC | ETHICON | USSC | 3M | | PeriPatch™<br>Sleeve | X | X | X | X | X | X | X | X | X | X | X | X | | Peri-Strips®<br>Sleeve | X | X | X | X | X | X | X | X | X | X | X | X | #### X - compatible The treatment and processing (relevant for the PeriPatch™ Sleeve) for cross-linking bovine pericardial tissue with glutaraldehyde is well described in the literature (Appendix A, Literature), and similar to those used in predicate devices, and has been validated (Appendix D, Validations). Sterilization is performed using a liquid alcoholic sterilant which is similar to the predicates and validated to be effective (Appendix D, Validations). The finished devices are packaged and labeled in a similar manner as the predicates (Section 6, Proposed Labeling; Appendix E, Predicate Device Labeling). The PeriPatch™ Sleeve * is considered to be similar to the Bio-Vascular predicate because: - Same raw material Bovine Pericardium - Same intended medical use - Operates using the same fundamental scientific technology . - . Similar shapes & sizes - . Similar method of processing - Similar method of sterilization - Similar packaging and labelling {2}------------------------------------------------ K037985 * The PeriPatch " Sleeve consists of a full sheet of processed bovine pericardial tissue. The Peri-Strip® Sleeve configuration consists of thin strips of bovine pericardium sutured to a polyethylene backing. Both devices are designed to fit a wide range of reusable, disposable and endoscopic staplers. This difference in the design of the two devices has no implications on the functionality or intended use of the device. #### 4c. Physical & Performance Characteristics The PeriPatch™ Sleeve is designed to reinforce at suture lines and stapling sites and to repair the body's natural organs and function like natural tissue. #### 4d. Safety & Effectiveness The device is designed and manufactured in such a way that, when used under the conditions and the purposes intended, it will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety. The safety and effectiveness of bovine pericardial patches used for reconstruction and repair are well characterized in the literature (Appendix A, References). They have been in use for over 20 years and have proven to be effective in achieving the desired result and well tolerated by host tissue. #### 5. Intended use of the Device Below is a list of the diseases or conditions that the device(s) will treat, prevent, cure or mitigate and a description: The PeriPatch™ Sleeve is intended for reinforcing staples and suture lines during a number of resection techniques - surgical repair of tissue deficiencies such as: - Lung volume reductions - Biopses . - . Lobectomies - . Gastric banding - Rectal and vaginal prolapse . - . Urethral sling - Other soft tissue repairs # 6. Technological Characteristics The device has the same technological characteristics as the predicate devices identified in Section 4-3. A comparison of the PeriPatch™ Sleeve to the predicate devices can be found in Table 4.3 on the next page. As shown in the table, the applicant device is substantially equivalent to the predicates technological characteristics. {3}------------------------------------------------ # PM DEVICES INC. – PERIPATCH™ SLEEVE 510(K) PREMARKET NOTIFICATION : | | PM Devices Inc. | PM Devices Inc. | Glycar Inc. | BioVascular | | BioVascular | | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Category | PeriPatch™ Sleeve | K031948 (PeriPatch™ Sheet) | K963967 | K983162 | K942010 | K921895 | Significance | | Indications for use | Surgical patch material to reinforce<br>surgical staples during stapling<br>procedures and for reinforcing suture<br>lines for cardiovascular and general<br>procedures. Resection techniques<br>include: lung volume reduction,<br>biopsies, lobectomies, gastric<br>banding, rectal and vaginal prolapse,<br>and urethral sling. | Surgical patch material to repair<br>intracardiac defects: septal (atrial /<br>ventrical) defects, great vessel and<br>annulus repair & suture line<br>reinforcement, repair of pericardial<br>structures, soft tissue deficiencies,<br>defects of abdominal and thoracic<br>wall, muscle flap reinforcement,<br>rectal and vaginal prolapse,<br>reconstruction of pelvic floor,<br>hernia(s), gastric banding. | Cardiac re-<br>construction &<br>repair, vascular<br>patching,<br>pericardial<br>closure | Repair of pericardial<br>structures, soft tissue<br>deficiencies, defects of the<br>abdominal and thoracic<br>wall, gastric banding,<br>muscle flap reinforcement,<br>rectal and vaginal prolapse,<br>reconstruction of the pelvic<br>floor, and hernias. | Peripheral vascular<br>repair/ re-<br>construction | For closure of the<br>patient's pericardium<br>& Peri-Strip sleeve<br>configuration - reinforce<br>staple lines during<br>segmental resections | PeriPatch indications<br>are same as<br>(combined) K983162<br>and PeriPatch Sleeve<br>indications are the<br>same as K921895<br>indications for the Peri-<br>Strip Sleeve<br>SE | | Materials | Bovine Pericardium | Bovine Pericardium | Same | Same | Same | Same | SE | | Processing | Glutaralde-hyde cross-linking fixation | Glutaralde-hyde cross-linking<br>fixation | Same | Same | Same | Same | SE | | Shape | Rectangular shaped tube | Flat, square & Rectangular | Not determined at<br>time of<br>submission | Flat, square & Rectangular | Flat, Rectangular | Rectangular & Peri-<br>Guard Sleeve, thin strips<br>of bovine pericardium<br>sutured to a polyethylene<br>backing | SE | | Sizes offered (cm) | See Table 4.1 & Table 4.2<br>Available to fit common staplers | 1.5x8<br>4x4<br>4x6<br>6x8<br>10x16<br>1.5x16 | Not determined at<br>time of<br>submission | 4x4<br>6x8<br>8x14<br>10x16 | 1.5x8<br>1.5x9<br>1.5x10<br>2x8<br>2x9<br>2x10<br>2.5x8<br>2.5x9<br>2.5x10 | 4x4<br>6x8<br>8x14<br>10x16<br>Peri-Guard Sleeves are<br>available in sizes to fit<br>common staplers | SE | | Packaging | Sealed, sterile container | Sealed, sterile container | Same | Same | Same | Same | SE | | Tissue THK (mm) | 0.58±0.17 | 0.58±0.17 | Unknown | 0.25 | 0.5±0.25 | 0.25 | SE | | Tensile Strength | 1172±311 g/m² | 1172±311 g/m² | Unknown | Unknown | 1080±330 g/m² | Unknown | SE | | Shrink Temp. | 86.2°C | 86.2°C | Unknown | Unknown | Unknown | Unknown | SE | | Suture Retention (g) | 969±114 | 969±114 | Unknown | Unknown | 1121±102 | Unknown | SE | | Elongation (%) | 46.1±5.4 | 46.1±5.4 | Unknown | Unknown | Unknown | Unknown | SE | | Burst Strength (mmHg<br>/psi) | 8200 / 159 | 8200 / 159 | Unknown | Unknown | 7033 / 136 | Unknown | SE | | Storage Solution | 0.2% Glutaralde-hyde / phosphate<br>buffered solution (PBS) | 0.2% Glutaralde-hyde / phosphate<br>buffered solution (PBS) | Propylene oxide<br>in water | Propylene oxide in water | Propylene oxide in<br>water | Propylene oxide in water | SE | | Rinse Instructions | Two 2 min. rinses | Two 2 min. rinses | Unknown | One 3 min. Rinse | One 3 min. rinse | One 3 min. Rinse | SE | | Sterility Method & | Liquid Alcoholic | Liquid Alcoholic | Unknown | Same | Same | Same | SE | # Table 4.3 - Similarities of the PeriPatch™ Sleeve to the predicate devices {4}------------------------------------------------ Image /page/4/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 an abstract image of an eagle with three stylized lines representing its wings. JUN - 4 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Britta Dombovari Quality Assurance, Regulatory Affairs PM Devices, Inc. 2135 – 13700 Mayfield Place Richmond, British Columbia V6V 2E4 Canada Re: K033985 Trade/Device Name: PeriPatch™ Sleeve Processed Bovine Pericardial Sleeve Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: May 5, 2004 Received: May 7, 2004 Dear Ms. Dombovari: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered prior to May 20, 2017) in accordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic (1 tor) that the device, subject to the general controls provisions of the Act. The r ou may, diereleve, mans of the Act include requirements for annual registration, listing of general controls provision 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 If your device is classined (tional controls. Existing major regulations affecting your device can may oc subject to such academa segulations, 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 r lease be devilsed that I Dri breasan that your device complies with other requirements of the Act that I DA has Intacts and regulations administered by other Federal agencies. You must or any I edital 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 CI IT fat 6077, abound (21 CFR Part 820); and if applicable, the electronic form in the quality byseller ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {5}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) I mis tetter will and n your your finding of substantial equivalence of your device to a legally premated 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 If you desire specific and Compliance at (301) 594-4659. Also, please note the regulation entitled, Connact the Office of Comments to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionitation on Journer 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 M. Melkerson 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 {6}------------------------------------------------ 510(k) Number (if known) K033985 Device Name: PeriPatch™ Sleeve Processed Bovine Pericardial Sleeve Indications For Use: The PeriPatch™ Sleeve is intended for use as a surgical patch mesh material to The PeriPatch'" Sleeve is intended to "ass and for reinforcing suture lines for reinforce surgical staples during stapling pocedures and for reinforce to the stapler reinforce surgical staples duning stapling proodaries carried out according to the stapler cardiovascular and general procedures. Stapling is carried rounding to the stapler cardiovascular and general procedures. Staping is our associations and during a manufacture's instructions. The sleeves are intenses lobiosies bionsies manufactures Instructions. The sleeves and includions, biopsies, lobectomies, humber of resection techniques out is they gastric banding, rectal and vaginal prolapse, and urethral sling. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |------------------------------------------------------------|-------------------------------| | (Division Sign-Off) | | | Division of General, Restorative, and Neurological Devices | | | 510(k) Number | _____________________________ | | Prescription Use | X | OR | Over-The-Counter Use | _____________________________ | |----------------------|---|----|----------------------|-------------------------------| | (Per 21 CFR 801.109) | | | | |