(76 days)
Not Found
No
The device description and intended use clearly describe a xenograft patch made from bovine pericardium, with no mention of software, algorithms, or any technology that would incorporate AI or ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is described as a surgical patch material for reconstruction and repair of various tissues, including cardiac and vascular, which directly addresses disease or injury by restoring function.
No
The device description and intended use indicate that the PeriPatch Sheet is a surgical patch material used for reconstruction and repair of tissues, not for diagnosing conditions.
No
The device description clearly states it is a xenograft patch made from bovine pericardium, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for surgical repair and reconstruction of tissues within the body (cardiac, vascular, soft tissue). IVDs are used to examine specimens from the body (like blood, urine, tissue samples) to provide information about a patient's health status.
- Device Description: The description details a surgical patch made from bovine pericardium, designed to be implanted and function like natural tissue. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information.
Therefore, the PeriPatch Sheet is a surgical implant/patch, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DXZ, FTM
Device Description
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. The PeriPatch Sheet is available in 6 sizes, but can also be trimmed to specific size depending on the procedure. The PeriPatch Sheet is manufactured from glutaraldehyde fixed bovine pericardium. The treatment and processing for cross-linking bovine pericardial tissue with glutaraldehyde is well described in the literature, and similar to those used in predicate devices, and has been validated. Sterilization is performed using a liquid alcoholic sterilant which is similar to the predicates and validated to be effective. The finished devices are packaged and labeled in a similar manner as the predicates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cardiac, vascular, soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K031948, K983162, K963967, K942010, K921895, K830863
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
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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 - 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 |
|