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 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. It is identical to other marketed bovine pericardial patches. Extensive quality control procedures assure a consistent, high quality product for clinical use.
This document describes a 510(k) premarket notification for the "PeriPatch™ Sheet," a processed bovine pericardial patch. The submission claims substantial equivalence to previously cleared devices.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state "acceptance criteria" in a formalized, quantifiable manner for biological performance. Instead, it demonstrates substantial equivalence to predicate devices through comparisons of physical, chemical, and manufacturing characteristics. The reported device performance is presented as direct comparisons to these predicates.
| Characteristic | PM Devices Inc. PeriPatch (Reported Performance) | Predicate Device (e.g., BioVascular, Extracorporeal) | Significance (as stated in document) |
|---|---|---|---|
| Material | Bovine Pericardium | Bovine Pericardium | SE (Substantially Equivalent) |
| Cross-linking | Glutaraldehyde cross-linking | Glutaraldehyde cross-linking | SE |
| Shape | Flat, square & Rectangular | Flat, square & Rectangular | SE |
| Sizes (cm) | 1.5x8, 1.5x16, 4x4, 4x6, 6x8, 10x16 | Range of sizes, with overlaps with PeriPatch | SE |
| Packaging | Sealed, sterile container | Sealed, sterile container | SE |
| Thickness (mm) | 0.58 ± 0.17 | 0.25 (BioVascular), 0.5 ± 0.25 (BioVascular), 0.35 (Extracorporeal) | SE |
| Weight (g/m²) | 1172 ± 311 g/m² | 1080 ± 330 g/m² (BioVascular), 4360 ± 1600 g (Extracorporeal) | SE |
| Melting Point (°C) | 86.2°C | 83.6°C (Extracorporeal) | SE |
| Tensile Elongation (g) | 969 ± 114 | 1121 ± 102 (BioVascular), 1280 ± 108 (Extracorporeal) | SE |
| Tensile Strength (g) | 46.1 ± 5.4 | Unknown (BioVascular), 31.2 ± 6.0 (Extracorporeal) | SE |
| Burst Strength (mmHg) | 8200 / 159 | 7033 / 136 (BioVascular) | SE |
| Sterilization Agent | 0.2% Glutaraldehyde / PBS | Propylene oxide in water (BioVascular, Glycar) | SE |
| Rinsing Conditions | Two 2 min. rinses | One 3 min. Rinse (BioVascular), Three 2 min. rinse (Extracorporeal) | SE |
| Sterility Method | Liquid Alcoholic | Liquid Alcoholic (BioVascular, Extracorporeal) | SE |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of a clinical study or a specific, independent dataset used to evaluate the device's performance against defined acceptance criteria. Instead, it relies on comparisons of its physical and performance characteristics to predicate devices. The data provenance is derived from the manufacturing and characterization of the PeriPatch™ Sheet itself and "literature" and "validations" cited in Appendix A and D respectively, which are not provided in this excerpt. This is a retrospective comparison to existing, legally marketed devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. No independent "test set" with a ground truth established by experts is described. The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons rather than an independent clinical validation.
4. Adjudication Method for the Test Set
Not applicable. No "test set" or adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement
No. A MRMC comparative effectiveness study was not done. This is a premarket notification for a medical device (a xenograft patch), not an AI-assisted diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This question applies to AI/ML software, not to a physical medical device like the PeriPatch™ Sheet.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established performance and safety profiles of the predicate devices, as detailed in their 510(k) clearances and scientific literature. The PeriPatch™ Sheet aims to demonstrate that its characteristics are similar enough to these established devices to be considered substantially equivalent. It is based on engineering and material property comparisons rather than clinical outcomes or pathology data from a new study.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML system. There is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" for this type of device.
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K040835 510(K) SUMMARY SECTION 4
- 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
-
- 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
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$$\sim / \Psi$$
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 - 199Size (cm) | 1.5 × 8 | 1.5 x 16------------------------------------------------------------------------------------------------ | and and and and in the commend of the commend of the commend of the comment of4×4------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Status and Address & Address4 × 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 SheetModels (DXZ/FTM) * | 1.5P8 | 1.5P16 | 4P4 | 4P6 | 6P8 | 10P16 |
|---|---|---|---|---|---|---|
| PeriPatch SheetSizes (DXZ/FTM) | 1.5cmx8cm | 1.5cmx16cm | 4cmx4cm | 4cmx6cm | 6cmx8cm | 10cmx16cm |
| Bio-Vascular SupplePeri-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
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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.
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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 | BioVascularK983162 | Glycar Inc.K963967 | BioVascularK942010 | BioVascularK921895 | ExtracorporealK830863 | Significance |
|---|---|---|---|---|---|---|---|---|---|
| The PeriPatch Sheet isintended for use as a surgicalpatch material for: cardiacand vascular reconstructionand repair, soft tissuedeficiency repair andreinforcing the suture lineduring general surgicalprocedures. | The PeriPatch Sheet is intendedfor use as a surgical patchmaterial for: cardiac andvascular reconstruction andrepair. | Repair of pericardialstructures, soft tissuedeficiencies, defectsof the abdominal andthoracic wall, gastricbanding, muscle flapreinforcement, rectaland vaginal pro-lapse, reconstructionof the pelvic floor, andhernias. | Cardiac re-construction &repair, vascularpatching,pericardial closure | Peripheralvascular repair/re-construction | For closure of thepatient's pericardium& Peri-Strip sleeveconfiguration - reinforcestaple lines duringsegmental resections | Pericardial closure | PeriPatchindications aresame as(combined)K031948 andK983162. | ||
| 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 attime of submission | Same | Rectangular & Peri-GuardSleeve, thin strips ofbovine pericardiumsutured to a polyethylenebacking. | Same | SE | |
| Size (cm) | 1.5x81.5x164x44x66x810x16 | Same | 4x46x88x1410x16 | Not determined attime of submission | 1.5x81.5x91.5x102x82x92x102.5x82.5x92.5x10 | 4x46x88x1410x16Peri-Guard Sleeves areavailable in sizes to fitcommon 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 inwater | Propylene oxidein water | Propylene oxidein 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
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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.
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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
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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
§ 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.