Who is the manufacturer of PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16?

Pm Devices, Inc. filed the 510(k) submission for PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16 (K040835).

What is the FDA product code for PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16?

FTM. It is classified under 21 CFR 878.3300 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16?

PeriPatch™ Sheet (K031948); Supple Peri-Guard® Pericardium (K983162); Glycar Pericardial Patch (K963967); Vascu-Guard (K942010); Supple Peri-Guard (K921895); Hancock Pericardial Patch (K830863).

Who can help prepare an FDA 510(k) submission like PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16

K040835 · Pm Devices, Inc. · FTM · Jun 15, 2004 · General, Plastic Surgery

Device Facts

Record ID	K040835
Device Name	PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16
Applicant	Pm Devices, Inc.
Product Code	FTM · General, Plastic Surgery
Decision Date	Jun 15, 2004
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.3300
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The PeriPatch Sheet is intended for use as a surgical patch material for: cardiac and vascular reconstruction and repair, soft tissue deficiency repair and reinforcing the suture line during general surgical procedures.

Device Story

PeriPatch™ Sheet is a quadrilateral xenograft patch composed of glutaraldehyde-fixed bovine pericardium. It functions as a surgical patch material for cardiac and vascular reconstruction, soft tissue repair, and suture line reinforcement. The device is provided in various sizes and can be trimmed by the surgeon to fit specific procedural needs. It is intended for use by surgeons in clinical settings. The patch acts as a scaffold for tissue repair, mimicking natural tissue properties. It is supplied in a sterile, liquid alcoholic solution. The device is designed to be integrated into surgical workflows to provide structural support for damaged or deficient tissues.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including physical and performance characteristics such as thickness, weight, melting point, tensile elongation, tensile strength, and burst strength, compared against predicate devices. Sterilization and processing methods were validated for effectiveness.

Technological Characteristics

Material: Glutaraldehyde-fixed bovine pericardium. Form factor: Quadrilateral sheets in various sizes (1.5x8cm to 10x16cm). Sterilization: Liquid alcoholic sterilant (0.2% glutaraldehyde/PBS). Mechanical properties: Tensile strength 46.1±5.4g, Burst strength 8200/159 mmHg. Connectivity: None (standalone).

Indications for Use

Indicated for patients requiring cardiac and vascular reconstruction and repair, soft tissue deficiency repair, or reinforcement of suture lines during general surgical procedures.

Regulatory Classification

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.

Predicate Devices

PeriPatch™ Sheet (K031948)
Supple Peri-Guard® Pericardium (K983162)
Glycar Pericardial Patch (K963967)
Vascu-Guard (K942010)
Supple Peri-Guard (K921895)
Hancock Pericardial Patch (K830863)

Related Devices

K031948 — PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16 · Pm Devices, Inc. · Sep 16, 2003
K172660 — Duravess bovine pericardial vascular patch · Edwards Lifesciences, LLC · Nov 17, 2017
K082139 — EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700 · Edwards Lifesciences, LLC · Oct 23, 2008
K182493 — Bovine Pericardial Tissue Patch · Tisgenx · Jun 18, 2019
K142447 — PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch · Synovis Life Technologies, Inc. · Jan 7, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ #### K040835 510(K) SUMMARY SECTION 4 1. Submitters Name, Address etc.: # JUN 1 5 2004 PM Devices Inc. 2135 – 13700 Mayfield Place Richmond, British Columbia V6V 2E4, CANADA Ph: 604.270-4344 Fx: 604.270-4384 www.pmdevices.com Contact: Britta Dombovari Date: March 2004 PeriPatch™ Sheet 2. Name of Devices: Trade Name: Common Name: Processed bovine pericardial patch Classification Name: Currently: Intracardiac Patch or Pledget -Class II-Product Code: DXZ Expanded Indications: Mesh, surgical, polymeric –Class Il-Product Code: FTM - 3. Predicate Devices: Legally marketed devices which PM Devices Inc. claims substantial equivalence: | Predicate Device | Manufacture | 510(k) # | Class | |--------------------------------|------------------|----------|-------| | PeriPatch™ Sheet | PM Devices Inc. | K031948 | II | | Supple Peri-Guard® Pericardium | BioVascular Inc. | K983162 | II | | Glycar Pericardial Patch | Glycar Inc. | K963967 | II | | Vascu-Guard | BioVascular Inc. | K942010 | II | | Supple Peri-Guard | BioVascular Inc | K921895 | II | | Hancock Pericardial Patch | Extrcorpeal | K830863 | II | All of the above previously cleared products are composed of processed bovine pericardium and are all used as a mesh material for surgical repair of pericardial structures and soft tissue deficiencies. # 4. Device Description: # 4a. How the Device Works # PeriPatch™ Sheet The PeriPatch™ Sheet is a quadrilateral shaped xenograft patch made from a sheet of glutaraldehyde fixed bovine pericardium selected for even thickness. It is designed to repair the body's natural organs and functions like natural tissue. It is intended for intra-cardiac repair procedures. A picture of a patch can be seen in Figure 1 - PeriPatch Sheet, and the engineering drawing can be found in Appendix C, Engineering Drawings. It is identical to other marketed bovine Extensive quality control procedures pericardial patches. assure a consistent, high quality product for clinical use. Image /page/0/Picture/15 description: In the image, a translucent rectangular object is being held by a pair of tweezers. The object appears to be thin and flexible, possibly made of plastic or a similar material. The tweezers are holding the object near one of its ends. The background is a dark, textured surface, which contrasts with the lighter color of the object and the tweezers. Figure 1 - PeriPatch Sheet The PeriPatch Sheet is available in 6 sizes (Table 4.1 – page 4-2), but can also be trimmed to specific size depending on the procedure. 4 {1}------------------------------------------------ $$\sim / \Psi$$ # Table 4.1 PeriPatch Sheet Model Numbers & Dimensions | Comments of Concession Commend Commend Comments of Concession Come of Concession Come of Concession Come of Concession Come of Concession of Concession of Concession of Conce | 1.5P8 | 1 | A . A . A | A | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 10P16 | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Model | | 1.5P16 | 4P4 | 4P6 | e68 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | September 1998 - 1998 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 199 Size (cm) | 1.5 × 8 | 1.5 x 16 ------------------------------------------------------------------------------------------------ | and and and and in the commend of the commend of the commend of the comment of 4×4 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Status and Address & Address 4 × 6 | 6×8 | 10 x 16 . | # 4b. Scientific Concepts #### PeriPatch Sheet The PeriPatch Sheet is manufactured from glutaraldehyde fixed bovine pericardium, this is the The I Chi aten Oneono mananate devices. Physical configuration of the PeriPatch sheet is similar to predicate patches, see Table 4.2 below: Table 4.2: Comparison of PeriPatch Sheet sizes available to current predicate devices. | PeriPatch Sheet Models (DXZ/FTM) * | 1.5P8 | 1.5P16 | 4P4 | 4P6 | 6P8 | 10P16 | |-------------------------------------------|-----------|------------|---------|---------|---------|-----------| | PeriPatch Sheet Sizes (DXZ/FTM) | 1.5cmx8cm | 1.5cmx16cm | 4cmx4cm | 4cmx6cm | 6cmx8cm | 10cmx16cm | | Bio-Vascular Supple Peri-guard Patch** | N/A | N/A | 4cmx4cm | N/A | 6cmx8cm | 10cmx16cm | | Bio-Vascular Vascu- Guard*** | 1.5cmx8cm | N/A | N/A | N/A | N/A | N/A | * PeriPatch Sheet (DXZ) – K031948 ** Bio-Vascular Supple Peri-guard Patch - K981895 *** Bio-Vascular Vascu-Guard – K942010 The treatment and processing (relevant for the PeriPatch Sheet) 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 Sheet is considered to be similar to the PeriPatch Sheet and Bio-Vascular predicates 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 # 4c. Physical & Performance Characteristics The PeriPatch Sheet is designed to repair the body's natural organs and function like natural tissue. ## 4d. Safety & Effectiveness The devices are designed and manufactured in such a way that, when used under the conditions and the purposes intended, they will not compromise the clinical condition or the {2}------------------------------------------------ safety of patients, or the safety and health of users or, where applicable, other persons, sancity of patients, or the carety as associated with their use constitute acceptable risks provided that any hiske we 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 r rie salely and encoments of sture (Appendix A, Literature). They have been in use for are well one of 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 will treat, prevent, cure or mitigate and a description: The PeriPatch Sheet has been approved for the following intended use: - Surgical patch material for cardiac and vascular reconstruction and repair. The intended expanded indications for use would include: - ... soft tissue deficiency repair and reinforcing the suture line during general surgical procedures. ## 6. Technological Characteristics The devices have the same technological characteristics as the predicate devices identified in Section 4-3. A comparison of the PeriPatch Sheet 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™ SHEET 510(K) PREMARKET NOTIFICATION able 4.3 - Similarities of the PeriPatch Sheet to the predicate devices | Number | Use | PM Devices Inc. PeriPatch (DXZ & FTM) | PM Devices Inc. PeriPatch (DXZ) K031948 | BioVascular K983162 | Glycar Inc. K963967 | BioVascular K942010 | BioVascular K921895 | Extracorporeal K830863 | Significance | |------------------------|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|----------------------------------------------------------------------------------| | | | The PeriPatch Sheet is intended for use as a surgical patch material for: cardiac and vascular reconstruction and repair, soft tissue deficiency repair and reinforcing the suture line during general surgical procedures. | The PeriPatch Sheet is intended for use as a surgical patch material for: cardiac and vascular reconstruction and repair. | Repair of pericardial structures, soft tissue deficiencies, defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, rectal and vaginal pro- lapse, reconstruction of the pelvic floor, and hernias. | Cardiac re- construction & repair, vascular patching, pericardial closure | Peripheral vascular repair/ re-construction | For closure of the patient's pericardium & Peri-Strip sleeve configuration - reinforce staple lines during segmental resections | Pericardial closure | PeriPatch indications are same as (combined) K031948 and K983162. | | | Bovine Pericardium | Same | Same | Same | Same | Same | Same | Same | SE | | | Glutaraldehyde cross-linking | Same | Same | Same | Same | Same | Same | Same | SE | | | Flat, square & Rectangular | Same | Same | Same | Not determined at time of submission | Same | Rectangular & Peri-Guard Sleeve, thin strips of bovine pericardium sutured to a polyethylene backing. | Same | SE | | Size (cm) | | 1.5x8 1.5x16 4x4 4x6 6x8 10x16 | Same | 4x4 6x8 8x14 10x16 | Not determined at time of submission | 1.5x8 1.5x9 1.5x10 2x8 2x9 2x10 2.5x8 2.5x9 2.5x10 | 4x4 6x8 8x14 10x16 Peri-Guard Sleeves are available in sizes to fit common staplers | 5x12 | SE | | | | | | | | | | | | | | Sealed, sterile container | Same | Same | Same | Same | Same | Same | Same | SE | | Thickness (mm) | | 0.58±0.17 | Same | 0.25 | Unknown | 0.5±0.25 | 0.25 | 0.35 | SE | | Weight (g/m) | | 1172±311 g/m2 | Same | Unknown | Unknown | 1080±330 g/m2 | Unknown | 4360±1600 g | SE | | Melting Point (°C) | | 86.2°C | Same | Unknown | Unknown | Unknown | Unknown | 83.6°C | SE | | Tensile Elongation (g) | | 969±114 | Same | Unknown | Unknown | 1121±102 | Unknown | 1280±108 | SE | | Tensile Strength (g) | | 46.1±5.4 | Same | Unknown | Unknown | Unknown | Unknown | 31.2±6.0 | SE | | Burst Strength (mmHg) | | 8200 / 159 | Same | Unknown | Unknown | 7033 / 136 | Unknown | Unknown | SE | | Sterilization | | 0.2% Glutaralde-hyde / phosphate buffered solution (PBS) | Same | Propylene oxide in water | Propylene oxide in water | Propylene oxide in water | Propylene oxide in water | Same | SE | | Rinsing Conditions | | Two 2 min. rinses | Same | One 3 min. Rinse | Unknown | One 3 min. rinse | One 3 min. Rinse | Three 2 min. rinse | SE | | Sterility Method | | Liquid Alcoholic | Same | Same | Unknown | Same | Same | Same | SE | |<040835 c/4 {4}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three stylized waves or lines, which may represent the flow of information or resources. The image is black and white. Public Health Service JUN 1 5 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Britta Dombovari Regulatory Affairs/Quality Assurance PM Devices, Inc. 2135-13700 Mayfield Place Richmond, British Columbia V6V 2E4 Canada Re: K040835 Trade/Device Name: PeriPatch™ Sheet Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: March 29, 2004 Received: March 31, 2004 Dear Ms. Dombovari: We have reviewed your Section 510(k) premarket notification of intent to market the device i we nave teviewed your bection of the device is substantially equivalent (for the indications felerenced above and nave determined and and and and one inces marketed in interstate for use stated in the encrosule) to regars actual date of the Medical Device Amendments, or to commerce prior to May 28, 1976, the enactment date of the Medical Device Americ commerce prior to May 20, 1770, the enastance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmelle Act (Act) market the device, subject to the general controls provisions of the Act. The r ou may, merciole, market the act include requirements for annual registration, listing of general controls provisions of use ice, 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 classified (sociation major regulations affecting your device can may be subject to such additional controls. Existing major regulations of the contract hilly be subject to suell additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Obas neements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised hiat i Dri s issuated on a business with other requirements of the Act that I DA has made a colorimiation administered by other Federal agencies. You must of any Federal statutes and regulations damading, but not limited to: registration and listing (21 comply with an the Ace STequirements, were 801); good manufacturing practice requirements as set and CFR Part 807), adocing (21 OFF Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. {5}------------------------------------------------ Page 2 - Ms. Britta Dombovari This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manieting your antial equivalence of your device to a legally premarket notification. THC FDA mixing of substantial equate 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 advice ion your ac not and subser note the regulation entitled, contact the Office of Complanes as (Set notification" (21CFR Part 807.97). You may obtain Misorallung by release to promance no promance notice ander the Act from the Division of Small other general information on your response at its toll-free number (800) 638-2041 or Manufacturers, International and Soless http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Muriam C. Provost (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}------------------------------------------------ # Indications for Use 510(k) Number (if known): K040835 Device Name: PeriPatchTM Sheet - Processed Bovine Pericardial Pati Indications For Use: The Por Use. The Por Parch sheet is intended for intended for works of a construction The Perforth 5neet 15 Orders and vasular re-constitution. Patch material for ; cardiac and vasular and soft fissne deficiency repair and repair surgical 1 general the mitche line during re inforcing procedures . Prescription Use _ (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) Muriam C. Provost (Division Sign-Off Division of General, Restorative. and Neurological Devices 510(k) Number_K 040835