AFB (ABSORBABLE FOAM BUTTRESS)

K014183 · J&J Corporate Biomaterials Center · FTL · Jun 12, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K014183
• Device Name: AFB (ABSORBABLE FOAM BUTTRESS)
• Applicant: J&J Corporate Biomaterials Center
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Jun 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

AFB is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed.

Device Story

AFB (Absorbable Foam Buttress) is a sterile, single-use device consisting of a cartridge and anvil carrier with attached buttressing material. It integrates into endoscopic and open linear cutting/transecting staplers. During surgery, the device reinforces the staple line while tissue is simultaneously cut and stapled. It is used by surgeons in clinical settings (e.g., VATS, open cases). The material is a synthetic, bioabsorbable copolymer that degrades within 120 days. By providing reinforcement to the staple line, the device aims to improve surgical outcomes in tissue resection/transection procedures.

Clinical Evidence

No clinical data. Evidence consists of non-clinical bench testing (polymer composition, viscosity, foam thickness, pore size, tensile strength, moisture, residuals, force to fire, tear resistance) and preclinical animal studies evaluating pharmacokinetics, toxicology, biocompatibility, and absorbability.

Technological Characteristics

Synthetic bioabsorbable copolymer foam buttress; 0.03" (0.75 mm) thickness. Integrated into endoscopic and open linear staplers. Sterilized for single-patient use. Biocompatibility and absorption profile similar to synthetic absorbable sutures.

Indications for Use

Indicated for patients undergoing surgical procedures requiring soft tissue transection or resection where staple line reinforcement is necessary.

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

• Peri-Strips Dry (K921895, K923657, K940205, K942583, K971048, K992537)
• Seamguard (K955364, K001789)
• Coated Vicryl II (K915835)
• Monocryl (poliglecaprone 25) suture, dyed (K960653, K964072)

Submission Summary (Full Text)

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A.

### SUMMARY OF SAFETY AND EFFECTIVENESS JUN 1 2 2002

#### I. GENERAL INFORMATION

| Submitted By: | J&J Corporate Biomaterials Center, a<br>division of Ethicon<br>Rt. 22 West, P.O. Box 151<br>Somerville, NJ 08876-0151 |
|---------------|-----------------------------------------------------------------------------------------------------------------------|
| Tel: | [phone] |
| Fax: | [phone] |

Contact Person: David A. Dalessandro At address above

- Device Trade Name: B. AFB Common Name: Staple Line Reinforcement Material Classification Name: Mesh, Surgical, Polymeric
- C. Predicate Devices:

| Manufacturer | Product Name | 510(k) No. |
|--------------------|----------------------------------------------|----------------------------------------------------------------|
| Bio-Vascular, Inc. | Peri-Strips Dry® | K921895<br>K923657<br>K940205<br>K942583<br>K971048<br>K992537 |
| W.L. Gore | Seamguard™ | K955364<br>K001789 |
| Ethicon, Inc. | Coated Vicryl II | K915835 |
| Ethicon, Inc. | Monocryl (poliglecaprone 25)<br>suture, dyed | K960653<br>K964072 |

#### D. Device Description:

The AFB (Absorbable Foam Buttress) Reload is a sterile, single patient use device which consists of two components: a cartridge and an anvil carrier. A strip of buttressing material is attached to both the cartridge and anvil carrier. AFB reinforces the staple line in soft tissue while it is simultaneously being cut and stapled. AFB is prepared from a synthetic,

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bioabsorbable copolymer similar to that used in synthetic absorbable sutures.

The AFB is integrated into endoscopic and open linear cutting/transecting staplers and reload cartridges. The two product reload cartridge configurations are suitable for the Endopath™ Endoscopic Linear Cutter used for VATS cases and the Linear Cutter used for OPEN cases.

The dimensions of AFB with a 0.03" (0.75 mm) thickness, accommodates the above-cited Ethicon-Endosurgery devices:

| Device | Dimensions of AFB<br>(Attached to Staple<br>Cartridge) (inches) | Dimensions of AFB<br>(Attached to Staple Anvil<br>Carrier) (inches) |
|----------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------|
| Endoscopic Linear Cutter<br>45mm Application | 1.83 × 0.34 | 1.83 × 0.59 |
| Linear Cutter 75 mm<br>Application | 3.19 x 0.44 | 3.30 x 0.63 |

- E. Indications for Use:
AFB is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed.

- F. Technological Comparison:
Substantial equivalence for AFB is based upon two separate categories of predicate devices. The first category contains predicate devices that address the intended use, mechanism of use, and application (i.e., two marketed buttress materials, namely Peri-Strips Dry® manufactured by Bio-Vascular, Inc. and Seamguard™ manufactured by W. L. Gore).

The second category of predicate devices addresses the composition of AFB in regard to its biocompatibility, safety data, absorption, and biodegradability (i.e., Coated Vicryl II and Monocryl sutures).

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#### II. TESTING

#### A. Non-Clinical Testing

Non-clinical testing was conducted on AFB to characterize the product. This testing included polymer composition by NMR, inherent viscosity, foam thickness, pore size, tensile strength, moisture content, residuals, force to fire and tear resistance.

- Preclinical Testing B.
Preclinical testing on the copolymer was conducted in multiple species to establish pharmacokinetics, toxicology, biocompatibility, and absorbability. AFB, although bioabsorbed in < 120 days, was subjected to a preclinical testing regimen consistent with that for a long-term implant.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three faces.

Public Health Service

JUN 1 2 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David A. Dalessandro Director, Implantable Devices J & J Corporate Biomaterials Center A Division of Ethicon Route 22 West, P.O. Box 151 Somerville, NJ 08876-0151

Re: K014183

Trade/Device Name: AFB Regulation Number: 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: April 11, 2002 Received: April 15, 2002

Dear Mr. Dalessandro:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Mr. David A. Dalessandro

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 N. Millerson

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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# STATEMENT OF INTENDED USE

510(k) Number (if known): K014183

AFB Device Name:

J&J Corporate Biomaterials Center, Sponsor Name: a division of Ethicon

Indications for Use:

AFB is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed.

Do Not Write Below This Line -- Continue on Another Page if Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Over-The-Counter Use

Mark N. Millerson

Division Sign-Off) Division of General, Restorative and Neurological Devices

KO14183 510(k) Number _