MOISTAIR FLUID AIR TUBING SET

K974561 · American Medical Devices, Inc. · KYG · Feb 19, 1998 · Ophthalmic

Device Facts

• Record ID: K974561
• Device Name: MOISTAIR FLUID AIR TUBING SET
• Applicant: American Medical Devices, Inc.
• Product Code: KYG · Ophthalmic
• Decision Date: Feb 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4360
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

For infusion of fluid and air during vitrectomy.

Device Story

Moistair™ Fluid/Air Tubing Set is a sterile, single-use accessory used during vitrectomy surgery. During the procedure, surgeons must replace natural vitreous with balanced salt solution (BSS) and subsequently replace BSS with air if a retinal hole is present. To mitigate the risk of cataract development associated with dry air introduction, the device humidifies the air before it enters the eye. The clinician injects 1 cc of BSS into an injection port on the device's humidifying filter prior to use. The system consists of PVC tubing, a 0.22-micron filter, a stopcock, an IV spike, and a humidifying filter. It is operated by a surgeon in an operating room setting. The device ensures that air introduced into the eye is humidified, potentially reducing ocular tissue damage.

Clinical Evidence

Bench testing only. Sterility validation performed using AAMI Overkill Method to achieve a SAL of 10^-6. Pyrogenicity determined via LAL method. Residue levels for ethylene oxide, ethylene chlorohydrin, and ethylene glycol were measured and reported.

Technological Characteristics

Materials: PVC tubing, 0.22 micron Millipore filter, PVC 3-way stopcock, plastic drip chamber, plastic humidifying filter. Sterilization: ETO (AAMI Overkill Method). Packaging: Tyvek pouch with Polymylar sheath. Non-pyrogenic. Connectivity: None (mechanical fluid/air delivery system).

Indications for Use

Indicated for infusion of fluid and air during vitrectomy procedures.

Regulatory Classification

Identification

An ocular surgery irrigation device is a device intended to be suspended over the ocular area during ophthalmic surgery to deliver continuous, controlled irrigation to the surgical field.

Predicate Devices

• Grieshaber & Co. (not specified)

Submission Summary (Full Text)

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P.02
K974561

Image /page/0/Picture/2 description: The image shows a logo with the letter "A" in a white square on the left. To the right of the square is a black rectangle with several vertical white lines. To the right of the black rectangle is the text "AMERICAN MEDICAL DEVICES, Inc." The text is stacked vertically, with "AMERICAN" on top, followed by "MEDICAL", and then "DEVICES, Inc."

FEB 1 9 1998

1100 Northside Drive Atlanta, Georgia 30318

(Revised) February 12, 1998

## Premarket Notification [510(k)] Summary

Submitter: American Medical Devices, Inc 1100 Northside Drive Atlanta, GA 303 18 Phone: [phone] [phone] Fax:

Official Correspondent: Frank J. Tighe

Trade Name: The American Medical Devices, Inc., Moistair™ Pluid/Air Tubing Set.

Common Name: Fluid/Air Tubing Set

Registration Number: We have registered but have not received our application back as of this date.

Class: Class II

Class Name/Number: 880.5725

Panel: Ophthalmic

Product Code: FRN

Device Description: During a vitrectorny, it is necessary to irrigate balanced salt solution (BSS) into the eye to replace the natural vitreous. If a retinal hole is present, the surgeon must then replace the balanced salt solution (BSS) with air to prevent the fluid from remaining under the retina. One of the problems associated with fluid/air exchange is development of cataracts. The Moistair™ Tubing Set humidifies the dry air prior to introduction into the eye. In order to humidify the air, 1 cc of balanced salt solution (BSS) is injected into the injection port on the humidifying filter prior to use.

Page 1 Summ

| Toll-Free | Direct | Facsimile | Internet |
|--------------|--------------|--------------|-----------------------------------|
| 800-793-1473 | 404-815-5233 | 404-815-5235 | [e-mail] |

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Statement of indications for use. - For infusion of fluid and air during vitrectomy

## Substantial Equivalence Comparison

| | American Medical<br>Devices, Inc. | Grieshaber & Co. |
|----------------------------------------------------------------------|-----------------------------------|------------------|
| Packaging<br>Tyvek to Poly | X | X |
| For infusion of fluid and<br>Air during vitrectomy | X | X |
| Materials: PVC Tubing Line, .22 micron<br>Filter, Stopcock, IV Spike | X | X |
| Sterilization ETO | X | X |
| Humidifying Filter | X | X |

## Sterility

The Device will be ETO Sterilized.

The method used to validate the sterilization cycle is AAMI Overkill Method

Packaging Material: Tyvek Pouch with a Ploymylar Sheath.

The SAL is 10 to the -6.

The maximum levels of residues of ethylene oxide: 25 parts per million; ethylene chlorohydrin: 25 parts per million and ethylene glycol: 250 parts per million.

This device is non-pyrogenic and the LAL Method is used to make that determination.

Pyrogens: We control the manufacturing environment to lessen the likelihood of pyrogen causing bacteria. In addition the LAL Method is used to determine that each lot is non-pyrogenic.

Materials Use In Manufacture: PVC Tubing, .22 Micron Millipore Filter, PVC 3way stopcock, Plastic Drip Chamber, Plastic Humidifying Filter.

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Image /page/2/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.

FEB 1 9 1998

Mr. Frank J. Tighe Offical Correspondent American Medical Devices, Inc. 1100 Northside Drive Atlanta, GA 30318

Re: K974561 Trade Name: Moistair ™ Fluid Air Tubing Set Regulatory Class: II Product Code: 80 FRN Dated: December 3, 1997 Received: December 5, 1997

Dear Mr. Tighe:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Frank J. Tighe

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 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 devices, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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51D(k) Number (if known): __ K974561

Moistair Fluid Air Tubing Set Device Name:_

Indications For Use:

For infusion of fluid and air during vitrectomy.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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Division of Ophthalmic Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________

Prescription Use_ (Per 21 CFR 801.109)

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Over-The-Counter Use____

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