SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET

K091441 · Synergetics, Inc. · FRN · Oct 30, 2009 · General Hospital

Device Facts

• Record ID: K091441
• Device Name: SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET
• Applicant: Synergetics, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Oct 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synergetics Sterile Adjustable Gas Pressured Infusion Tube Set is intended to deliver forced humidified air or fluid to the eye during ophthalmic surgery.

Device Story

The Synergetics AGPI Tube Set is a sterile, single-use PVC tubing assembly used during ophthalmic surgery. It connects to an air supply unit and a bottle of Balanced Salt Solution (BSS). The device features a three-channel IV spike for BSS bottle insertion and a three-way stopcock for selecting between air or fluid delivery. One lumen delivers humidified air, while another delivers saline. The device is operated by a surgeon or clinical staff in an operating room setting. By providing controlled delivery of humidified air or fluid, the device assists in maintaining ocular pressure or irrigation during surgical procedures, facilitating surgical visualization and tissue management.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: PVC tubing. Components: Three-channel IV spike, three-way stopcock. Sterilization: Ethylene Oxide (EtO) per AAMI/ISO 11135. Packaging: Tyvek/Mylar pouch validated per ISO 11607-1:2006. Connectivity: None (mechanical fluid/gas delivery).

Indications for Use

Indicated for delivery of forced humidified air or fluid to the eye during ophthalmic surgery.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• Peregrine Wet Set (K990518)
• Alcon VGFI Tube Set (K911808)

Submission Summary (Full Text)

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## Synergetics Adjustable Gas Pressured Infusion Tube Set Section 5 510 (k) Summary Submitted in accordance with the requirements of 21 CFR 807.92

| Applicant's Name and Address: | Synergetics, Inc.<br>3845 Corporate Centre Drive<br>O'Fallon, MO 63368 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gary Oliveros<br>Synergetics, Inc.<br>Quality Systems/ Regulatory Affairs Manager<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |

OCT 3 0 2009

| Date Prepared: | May 14, 2009 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | Synergetics Sterile Adjustable Gas Pressured Infusion (AGPI) Tube Set |
| Common Name: | Air/ Fluid Tubing Set |
| Device Classification: | Class II |
| Class Name: | A review of the U.S. FDA's Product Code Classification Files at<br>http://www.fda.gov/cdrh/prdcddes.html indicates a similar type<br>device is not listed in 21 CFR Parts 862 - 892. |
| Product Code: | FRN |
| FDA Panel: | Ophthalmic |
| Predicate Device: | Peregrine Wet Set, K990518 |

#### Intended Use/ Device Description:

The Synergetics AGPI Tubing set is a PVC tubing set intended to deliver forced humidified air or fluid to the eye during ophthalmic surgery. The tubing set consists of a three channel IV spike, for insertion into a bottle of Balanced Salt Solution. The three way spike is designed to deliver air from an air supply unit through the solution; while the dual PVC tubing also administers humidified air (clear lumen) and saline (green stripe lumen); this dual PVC tubing has a three-way stopcock for proper connection.

#### Substantial Equivalence Basis:

This premarket notification contains descriptive information related to the intended use, operational characteristics and technological features that provide objective evidence that forms the basis of a substantial equivalence decision.

Section 5 - Page 1 of 2

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Comparison of Technical Characteristics:

| Predicate Device Comparison | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|----------------------------------------------------|------------------------------------|
| Criteria | Predicate Device<br>Peregrine Wet Set<br>K990518 | Predicate Device<br>Alcon VGFI Tube Set<br>K911808 | Synergetics, Inc.<br>AGPI Tube Set |
| Indications for Use | | | |
| Pressured Air Delivered from<br>Fluid Source | Bottle | Bottle/ system console | Bottle/ system console |
| Fluid Source | Bottle | Bottle | Bottle |
| Air System Required | Yes | Yes | Yes |
| 3 way stopcock for air/ fluid<br>selection | Yes | Yes | Yes |
| Extension tube for insertion into<br>BSS Solution | Yes | Yes | Yes |
| Delivery line for air to stopcock | Yes | Yes | Yes |
| Delivery line for fluid to<br>stopcock | Yes | Yes | Yes |
| Filtered Air Line for attachment<br>to air system | Yes | Yes | Yes |
| Single Use | Yes | Yes | Yes |
| Sterilization Method | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) |
| Packaging (See Note 1) | Not known | Rigid PETG Tray | Tyvek/ Mylar Pouch |
| Note 1: Synergetics packaging configuration has been validated in accordance with ISO 11607-1:2006,<br>Packaging for Terminally Sterilized Medical Devices- Part 1: Requirements for Materials, Sterile Barrier<br>Systems and Packaging Systems | | | |

### Quality Management System:

Synergetics is a BS EN 13485:2003 compliant company and is required to ensure our quality management system and design control practices fully comply with internal quality system standards and domestic regulations. Pursuant to our design control process, Synergetics has established a risk management process that ensures during the design validation phase, the safety and effectiveness of the device meets applicable input requirements and complies with applicable harmonized standards.

#### Risk Management:

Risk Management has been implemented and complies with ISO 14971, Medical Devices - Application of Risk Management to Medical Devices and GHTF/SGS/N15R8, Implementation of Risk Management Principles and Activities within a Quality Management System.

#### Sterilization Method:

Synergetics Adjustable Gas Pressured Infusion Tube Sets are sterilized in accordance with AAMI/ISO 11135 Medical Devices - Validation and routine control of ethylene oxide sterilization (EtO), Overkill Method.

Section 5 - Page 2 of 2

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

Synergetics, Inc. c/o Mr. Gary Oliveros Quality System/Regulatory Affairs Manager 3845 Corporate Centre Drive O' Fallon, MO 63368

OCT 8 0 2009

Re: K091441

Trade/Device Name: Synergetics Adjustable Gas Pressurized Infusion (AGPI) Tube Set Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: October 9, 2009 Received: October 13, 2009

Dear Mr. Oliveros:

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 Mcdical 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 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 device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Kesia Alexander for

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Synergetics™ 510 (k) Submission Synergetics Adjustable Gas Pressured Infusion (AGPI) Tube Set Section 4 - Indications for Use

## 510(k) Number (if known):

Synergetics Adjustable Gas Pressured Infusion (AGPI) Tube Set Device Name: The Synergetics Sterile Adjustable Gas Pressured Infusion Tube Indications for Use: Set is intended to deliver forced humidified air or fluid to the eye during ophthalmic surgery.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daryl Kautner

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear Nose and Throat Devices

510(k) Number***_***_