DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR

K972693 · Deroyal Industries, Inc. · HOZ · Sep 30, 1997 · Ophthalmic

Device Facts

• Record ID: K972693
• Device Name: DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR
• Applicant: Deroyal Industries, Inc.
• Product Code: HOZ · Ophthalmic
• Decision Date: Sep 30, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4790
• Device Class: Class 2

Intended Use

The DeRoyal Industries, Inc., Surgical Eye Spear is indicated for use in ophthalmic or microscopic surgical procedures to absorb fluids from the operative field.

Device Story

Device consists of absorbent cellulose spear attached to high-density polyethylene plastic handle; used in ophthalmic or microscopic surgical procedures to absorb fluids from operative field. Device is sterile, single-use, and manually operated by surgeon or surgical staff. Benefits include efficient fluid management during delicate procedures. No electronic or software components.

Clinical Evidence

No clinical data was required for this submission. Safety established via bench testing and biocompatibility assessments including cytotoxicity, sensitization, intraocular irritation, systemic injection, hemolysis, intracutaneous toxicity, and intracutaneous implantation.

Technological Characteristics

Materials: Cellulose (sponge), High Density Polyethylene (handle). Form factor: Triangular sponge head on plastic handle. Sterilization: Ethylene Oxide (SAL 10^-6). Biocompatibility: ISO 10993-1 and USP Class VI compliant.

Indications for Use

Indicated for use in ophthalmic or microscopic surgical procedures to absorb fluids from the operative field.

Regulatory Classification

Identification

An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Predicate Devices

• Ultracell Medical Technologies (K923922)

Submission Summary (Full Text)

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DeRoyal Industries, Inc. Surgical Eye Spear

K972693

510(k) Summarv

SEP 3 0 1997

## SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED

#### SUBMITTER INFORMATION

DeRoyal Industries, Inc. TELEPHONE: NAME: CONTACT: 200 DeBusk Lane ADDRESS: DATE OF PREPARATION: Powell, TN 37849

[phone] Camille Matlock September 19, 1997

### DEVICE NAMES

NAME: COMMON/USUAL NAME: CLASSIFICATION NAME (if known):

DeRoyal Industries, Inc., Surgical Eye Spear Eve Spear Sponge, Ophthalmic (86HOZ)

## PREDICATE OR LEGALLY MARKETED DEVICE

Ultracell Medical Technologies (K923922)

#### DEVICE DESCRIPTION

The DeRoyal Industries, Inc., Surgical Eye Spear functions in the same manner as predicate devices in that it is comprised of an absorbent spear attached to a plastic handle.

Device Design/Materials Used Physical Properties: The DeRoyal Industries, Inc., Surgical Eye Spear is made of materials commonly used in predicate devices. The spear is comprised of cellulose and the handle is made of a high density plastic.

Clinical Data was not required for this submission.

#### DEVICE INTENDED USE

The DeRoyal Industries, Inc., Surgical Eye Spear is indicated for use in ophthalmic or microscopic surgical procedures to absorb fluids from the operative field.

| Characteristics & Materials | DeRoyal Surgical Eye Spear | Predicate Device |
|-----------------------------|----------------------------------------------------------|------------------|
| Sponge Material | Cellulose | Same |
| Handle Material | High Density Polyethylene | Same |
| Shape | Triangular Sponge Head | Same |
| Sponge Tip Measurements | 11/16 inch (length)<br>9/32 inch (width) | ~Same |
| Plastic Handle Measurements | 2-3/16 inch (length)<br>.092 inch - .125 inch (diameter) | ~Same |
| Sizes | One Size | Same |
| Sterility | Sterile | Same |

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#### STERILITY INFORMATION

The device shall be offered sterile. The method of sterilization is Ethylene Oxide with a Sterility Assurance Level of 10°. The maximum levels of residues of ethylene oxide, ethylene chlorohydrin, and ethylene glycol allowed to remain on the device will meet the proposed maximum residual limits stated in the Federal Register, June 23, 1978.

## BIOCOMPATIBILITY TESTING

The following Biocompatibility tests were performed. All test results were deemed acceptable.

| TEST | REFERENCE |
|-----------------------------|-------------------------------|
| Cytotoxicity | ISO 10993-1 |
| Sensitization | ISO 10993-1 |
| Intraocular Irritation | ISO 10993-1 |
| Systemic Injection | ISO 10993-1 &<br>USP Class VI |
| Hemolysis | ISO 10993-1 |
| Intracutaneous Toxicity | USP Class VI |
| Intracutaneous Implantation | USP Class VI |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized emblem. The emblem consists of four abstract human profiles facing right, arranged in a stacked, overlapping manner. The profiles are black, and the text is in a simple, sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 0 1997

Ms. Camille Matlock Regulatory Affairs DeRoyal Industries, Inc. 200 DeBusk Lane Powell, TN 37849

Re: K972693

> Trade Name: DeRoyal Industries, Inc. Surgical Eye Spear Regulatory Class: II Product Code: 86 HOZ Dated: July 17, 1997 Received: July 18, 1997

Dear Ms. Matlock:

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 - Ms. Camille Matlock

This letter will allow you to begin marketing your device as described in your 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 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" (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 Roerl 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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# 510(k) Number (if known):

6912693

Device Name:

DeRoyal Industries Inc., Surgical Eye Spear

# Indications for Use:

The DeRoyal Industries Inc., Surgical Eye Spear is to be used to absorb fluids from the operative field during ophthalmic and microscopic surgical procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel W. C. Brown

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K912693

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OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________