Standard Clamp

K153358 · Standard Bariatrics · GDJ · May 2, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K153358
• Device Name: Standard Clamp
• Applicant: Standard Bariatrics
• Product Code: GDJ · General, Plastic Surgery
• Decision Date: May 2, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4800
• Device Class: Class 1

Indications for Use

The Standard Clamp is a hand held device used to clamp long planes of soft tissues. The device allows the surgeon to clamp and manipulate flat tissue and organs, such as the stomach. The clamp can also be used by the surgeon to help guide staplers during transection of tissue.

Device Story

Reusable, non-energized, stainless steel surgical instrument; used in open procedures. Comprised of handle, shaft, and end effector. User rotates two knobs on handle to articulate end effector (up to 55° from midline) and open/close jaws. Jaws close in parallel to grasp soft tissue/organs (e.g., stomach). Used by surgeons to manipulate tissue or guide staplers during transection. Device features flush port for cleaning. Steam sterilized.

Clinical Evidence

Bench and in vivo pre-clinical evaluation. Histological assessment compared tissue effects of the Standard Clamp against surgical staplers, soft tissue clamps, and graspers. Results showed the Standard Clamp caused little to no tissue effect, exhibiting less damage than standard graspers and staplers, and performing comparably to the Doyen clamp.

Technological Characteristics

Stainless steel construction; non-energized; manually articulated. Dimensions: 25.4 inches (64.5 cm) length; 1.7 lbs weight. Features: inline grip handle, two-knob articulation mechanism, parallel-closing jaws with non-piercing ridges, and flush port. Sterilization: steam autoclave. Biocompatible for limited duration blood/bone/tissue contact.

Indications for Use

Indicated for use in open surgical procedures to grasp, clamp, and manipulate soft tissues.

Regulatory Classification

Identification

A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.

Predicate Devices

• Doyen Atraumatic Bowel Clamp (SCR25)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The eagle is facing right, and the profiles are stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 2, 2016

Standard Bariatrics Ms. Alison Sathe Director Of Regulatory 4362 Glendale Milford Rd. Cincinnati, Ohio 45242

Re: K153358

Trade/Device Name: Standard Clamp Regulation Number: 21 CFR 878.4800 Regulation Name: Manual Surgical Instrument For General Use Regulatory Class: Class I Product Code: GDJ Dated: March 27, 2016 Received: April 4, 2016

Dear Ms. Alison Sathe:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K153358

Device Name Standard Clamp

Indications for Use (Describe)

The Standard Clamp is indicated for use in open procedures to grasp, clamp, and manipulate soft tissues.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image is a logo for Standard Bariatrics. The logo features a stylized red "S" on the left, followed by the words "STANDARD" and "BARIATRICS" in black, stacked on top of each other. The "S" is made up of three horizontal lines, and the word "BARIATRICS" has a trademark symbol next to it.

## 510(K) Summary

This 510(K) Summary of safety and effectiveness for the Standard Clamp is submitted in accordance with 21 CFR 807.92.

| Submitter Information | |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant Name | Standard Bariatrics |
| Address | Standard Bariatrics<br>4362 Glendale Milford Road<br>Cincinnati, OH 45242 USA |
| Contact Person | Alison Sathe<br>Regulatory, Standard Bariatrics<br>513-304-7971<br>[e-mail] |
| Preparation Date | December 7, 2015 |
| Device Information | |
| Device Trade Name | Standard Clamp |
| Common Name | Manual Surgical Instrument |
| Classification Name | Manual surgical instrument for general use |
| Classification Panel | 79 General and Plastic Surgery |
| Regulation | Class I per 32 CFR 878.4800, product code GDJ |
| Legally Marketed Predicate<br>Device(s) | Doyen Atraumatic Bowel Clamp |
| Product Code | SCR25 |
| Reason for 510(k) | New Device |
| Device Description | The Standard Clamp is a reusable, non-energized, stainless steel surgical instrument. The instrument is comprised of three main sections: handle, shaft, and end effector. The handle is an inline grip with two knobs which are manually rotated in order to manipulate the end effector. The end effector of the clamp is comprised of an upper and lower jaw that close parallel in order to grasp tissue. |
| Intended Use | The Standard Clamp is a hand held device used to clamp long planes of soft tissues. The device allows the surgeon to clamp and manipulate flat tissue and organs, such as the stomach. The clamp can also be used by the surgeon to help guide staplers during transection of tissue. |
| Indications for Use: | The Standard Clamp is indicated for use in open procedures to grasp, clamp and manipulate soft tissues |

Technological Characteristics: The Standard Clamp is a non-energized, manually articulated, surgical clamp. The device is comprised of stainless steel and is validated for sterilization by steam autoclave. Two knobs on the device handle allow the user to adjust the angle of the end effector with respect to the shaft and open/close the jaws. Technical specifications are as follows:

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Standard Bariatrics. The logo consists of a red, stylized letter "S" enclosed in a rounded square on the left. To the right of the symbol, the words "STANDARD" and "BARIATRICS" are written in bold, black capital letters, stacked vertically. A small trademark symbol appears next to the word "BARIATRICS".

| Product | Standard Clamp | Doyen Atraumatic Bowel Clamp |
|-----------------------------|--------------------------------------------------|-----------------------------------------------|
| Type of Device | Reusable | Reusable |
| Materials (end<br>effector) | Stainless Steel | Stainless Steel |
| Length | 25.4 inches (64.5 cm) | 9 inches |
| Weight | 1.7 lbs. | unknown |
| Articulation<br>Mechanism | Rotating knob on handle | none |
| Articulation | up to 55° from midline | Available in curved or straight configuration |
| End effector design | Stainless steel jaws with non-piercing ridges to | Stainless steel jaws with non-piercing ridges |
| | grasp tissue | to grasp tissue |
| End effector closure | Parallel closure | Scissor-type closure |
| Handle | In-line grip | In-line grip |
| Sterilization Method | Steam Sterilization | Steam Sterilization |
| Flush Port | Yes | No |
| Anatomical Site Used | Various soft tissues | Various soft tissues |
| Energy Delivered | No | No |
| Biocompatibility | Biocompatible for blood/bone/tissue contact | Biocompatible for blood/bone/tissue contact |
| | for limited duration | for limited duration |

# Performance Data:

Pre-clinical evaluation of the Standard Clamp was performed to ensure the device may be used as designed. The device ability to clamp the stomach was evaluated in vivo. Tissue effects from the Standard Clamp were compared to other surgical devices including surgical staplers, soft tissue clamps, and graspers in a histological assessment. The Standard Clamp demonstrated little or no tissue effect after being clamped on stomach for an extended period of time as observed under histology. The Standard Clamp exhibited less tissue damage compared to graspers and surgical staplers with the exception of the Doyen clamp which also demonstrated no damage to tissue. Testing demonstrates acceptable performance of the Standard Clamp, its ability to clamp the stomach, and non-traumatic tissue effect.

# Substantial Equivalence:

The Standard Clamp has the same indications, technological characteristics, principles of operation as its predicate devices. There are no new issues of safety or effectiveness. Thus, the Standard Clamp is substantially equivalent to the predicate devices.