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

• K Number: K033985
• Device Name: PERIPATCH SLEEVE, MODELS G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10
• Manufacturer: PM DEVICES, INC.
• Date Cleared: 2004-06-04 ( 164 days)
• Product Code: FTM
• Regulation Number: 878.3300

Intended Use

The PeriPatch™ Sleeve is intended for use as a surgical patch mesh material to reinforce surgical staples during stapling procedures and for reinforcing suture lines for cardiovascular and general procedures. Stapling is carried out according to the stapler manufacture's instructions. The sleeves are intended for a number of resection techniques including: lung volume reductions, biopsies, lobectomies, gastric banding, rectal and vaginal prolapse, and urethral sling.

Device Description

PeriPatch™ Sleeve consists of one piece of The qlutaraldehyde fixed bovine pericardium that is sutured into a rectanqular shaped tube. 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 The suture is removed and the remaining pericardial tissue is withdrawn with the excised host tissue.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.

Predicate Devices

K031948, K963967, K983162, K942010, K921895

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the material and mechanical function of a surgical patch, with no mention of AI or ML capabilities.

Therapeutic

No.
The device is described as a surgical patch mesh material used to reinforce surgical staples and suture lines. Its function is to provide structural support during and after surgical procedures, not to treat a disease, injury, or condition directly in a therapeutic manner.

Diagnostic

No

Explanation: The device is described as a surgical patch mesh material used to reinforce surgical staples and suture lines. Its purpose is to aid in surgical procedures, not to diagnose conditions or diseases.

SaMD (Software as a Medical Device)

No

The device is described as a physical surgical patch mesh material made from bovine pericardium, which is a hardware component.

IVD (In Vitro Diagnostic)

Based on the provided information, the PeriPatch™ Sleeve is not an IVD (In Vitro Diagnostic) device.

Here's why:

• IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
• PeriPatch™ Sleeve Function: The PeriPatch™ Sleeve is a surgical patch material intended for direct use within the body during surgical procedures to reinforce staples and suture lines. It is a surgical implant/accessory, not a device used for testing bodily specimens.

The description clearly indicates its use in surgical procedures on patients, not for laboratory testing of samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The PeriPatch™ Sleeve is intended for use as a surgical patch mesh material to reinforce surgical staples during stapling procedures and for reinforcing suture lines for cardiovascular and general procedures. Stapling is carried out according to the stapler manufacture's instructions. The sleeves are intended for a number of resection techniques and include: lung volume reductions, biopsies, lobectomies, gastric banding, rectal and vaginal prolapse, and urethral sling.

Product codes

FTM

Device Description

PeriPatch™ Sleeve consists of one piece of The qlutaraldehyde fixed bovine pericardium that is sutured into a rectanqular shaped tube. 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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)

K031948, K963967, K983162, K942010, K921895

Reference Device(s)

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

Regulation Number and Section

§ 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.

Summary

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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.
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: December, 2003
2. Name of Devices:	Trade Name: PeriPatch™ Sleeve1
Common Name: Processed bovine pericardial sleeve
Classification Name:
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;
Ethicon TLC 55
E35-1, -2, -5	Ethicon EZ 35B	5c8-1, -2, -5	Auto Suture Endo GIA 80;
Ethicon TLC 75
G45-1, -2, -5	Auto Suture Endo GIA 45	5c10-1, -2, -5	Auto Suture Endo GIA 90
(re-useable);
Auto Suture Endo GIA 90
(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
Linear | | | |
|-------------------------|-------------------|-------------------|-----------------|------------------------|-------------------|-----------|---------|-----------|--------------------|---------|-----------|------------|
| | GIA
ENDO
60 | GIA
ENDO
30 | ENDOP
ATH 60 | ENDOP
ATCH
EZ 45 | ENDOP
ATH 35 | GIA
80 | TLC 75 | ILA
75 | GIA
60 | TLC 55 | GIA
90 | ILA
100 |
| Stapler
Manufacturer | USSC | USSC | ETHICON | ETHICON | ETHICON | USSC | ETHICON | 3M | USSC | ETHICON | USSC | 3M |
| PeriPatch™
Sleeve | X | X | X | X | X | X | X | X | X | X | X | X |
| Peri-Strips®
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.

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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
surgical staples during stapling
procedures and for reinforcing suture
lines for cardiovascular and general
procedures. Resection techniques
include: lung volume reduction,
biopsies, lobectomies, gastric
banding, rectal and vaginal prolapse,
and urethral sling.	Surgical patch material to repair
intracardiac defects: septal (atrial /
ventrical) defects, great vessel and
annulus repair & suture line
reinforcement, repair of pericardial
structures, soft tissue deficiencies,
defects of abdominal and thoracic
wall, muscle flap reinforcement,
rectal and vaginal prolapse,
reconstruction of pelvic floor,
hernia(s), gastric banding.	Cardiac re-
construction &
repair, vascular
patching,
pericardial
closure	Repair of pericardial
structures, soft tissue
deficiencies, defects of the
abdominal and thoracic
wall, gastric banding,
muscle flap reinforcement,
rectal and vaginal prolapse,
reconstruction of the pelvic
floor, and hernias.	Peripheral vascular
repair/ re-
construction	For closure of the
patient's pericardium
& Peri-Strip sleeve
configuration - reinforce
staple lines during
segmental resections	PeriPatch indications
are same as
(combined) K983162
and PeriPatch Sleeve
indications are the
same as K921895
indications for the Peri-
Strip Sleeve
SE
Materials	Bovine Pericardium	Bovine Pericardium	Same	Same	Same	Same	SE
Processing	Glutaralde-hyde cross-linking fixation	Glutaralde-hyde cross-linking
fixation	Same	Same	Same	Same	SE
Shape	Rectangular shaped tube	Flat, square & Rectangular	Not determined at
time of
submission	Flat, square & Rectangular	Flat, Rectangular	Rectangular & Peri-
Guard Sleeve, thin strips
of bovine pericardium
sutured to a polyethylene
backing	SE
Sizes offered (cm)	See Table 4.1 & Table 4.2
Available to fit common staplers	1.5x8
4x4
4x6
6x8
10x16
1.5x16	Not determined at
time of
submission	4x4
6x8
8x14
10x16	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	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
/psi)	8200 / 159	8200 / 159	Unknown	Unknown	7033 / 136	Unknown	SE
Storage Solution	0.2% Glutaralde-hyde / phosphate
buffered solution (PBS)	0.2% Glutaralde-hyde / phosphate
buffered solution (PBS)	Propylene oxide
in water	Propylene oxide in water	Propylene oxide in
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

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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 [phone]. 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 [phone] or [phone] 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

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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)