K Number
K992978
Device Name
RICROKERATOME BLADE
Manufacturer
Date Cleared
1999-11-16

(74 days)

Product Code
Regulation Number
886.4370
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Surgistar Microkeratome is indicated for use as a replacement blade in the Chiron Vision Automatic Corneal Shaper Surgical Instrument (ACS). The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.
Device Description
Replacement Stainless Steel Blade for Chiron Automatic Corneal Shaper Blade
More Information

Not Found

No
The summary describes a replacement surgical blade and does not mention any AI or ML capabilities.

No
This device is a replacement blade for a surgical instrument, not a therapeutic device itself, although the instrument it's part of is used in a therapeutic procedure.

No
The device is a replacement blade for a surgical instrument used in corneal resection, which is a therapeutic procedure, not a diagnostic one.

No

The device is a physical replacement blade, not software.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is as a replacement blade for a surgical instrument used in corneal surgery. This is a surgical device, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
  • Device Description: It's a replacement blade, a physical component used in a surgical procedure.
  • Anatomical Site: The cornea is a part of the human body being operated on, not a specimen being tested.

IVD devices are typically used in laboratories or point-of-care settings to analyze samples like blood, urine, tissue, etc., to provide diagnostic information. This device is a surgical tool used directly on the patient during a procedure.

N/A

Intended Use / Indications for Use

The Surgistar Microkeratome is indicated for use as a replacement blade in the Chiron Vision Automatic Corneal Shaper Surgical Instrument (ACS). The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.

Product codes

86 HNO

Device Description

Replacement Stainless Steel Blade for Chiron Automatic Corneal Shaper Blade

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

CORNEA

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K941550

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 886.4370 Keratome.

(a)
Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.(b)
Classification. Class I.

0

NOV I 6 1999

Surgistar Inc. Microkeratome Blade

K992978

November 1, 1999 510k No. K992978

510(K) Summary (As required by 21 CFR 807.92)

Page 1 of 3

Submitter:

Surgistar, Inc. 6068 Corte Del Cedro Carlsbad, CA. 92009

Contact person:

Jonathan Woodward

Telephone:

(760) 431-7400 Fax: (760) 431 6768

Trade name:Surgistar Microkeratome Blade
Common name:Microkeratome Blade
Classification name:Microkeratome Blade

Legally marketed device to which we are claiming equivalence:

Chiron Vision Corp Automatic Corneal Shaper Surgical Instrument (BLADE ONLY) 510(k) Number - K941550

Description of the Device:

Replacement Stainless Steel Blade for Chiron Automatic Corneal Shaper Blade

Intended use of the device:

Replacement Blade for Chiron Automatic Corneal Shaper Blade

1

Surgistar Inc. Microkeratome Blade

November 1, 1999 510k No. K992978

Page 2 of 3 Summary

Summary of Technological characteristics of device compared to predicate device.(Section 807.92(a)(6)

| CHARACTERISTICS | AUTOMATIC CORNEAL SHAPER BLADE
ONLY(PREDICATE-) | Surgistar
MICROKERATOME
Prod No. 2200 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| INTENDED USE | FOR PERFORMING LAMELLAR RESECTIONS OF
THE CORNEA | SAME |
| OPERATION
PRINCIPLE | BLADE IS HELD IN ELECTRICALLY DRIVEN
OCILLATING HEAD (PROVIDED BY ORIGINAL
EQUIPMENT MANUFACTURER Eg CHIRON)
WHICH GUIDES BLADE ACROSS CORNEA | SAME |
| PATIENT CONTACT
PORTION OF DEVICE | BLADE | SAME |
| MATERIALS | LOW CARBON STAINLESS STEEL | SAME |
| STERILIZATION
METHOD (BLADE) | EO | RADIATION-GAMMA |

2

Page 3 of 3 Summary

DIMENSIONAL & SHARPNESS EQUIVALENCY CHART

| ATTRIBUTE | CHIRON ACS
BLADE
AS MEASURED | SURGISTAR
MICRO KERATOME BLADE
SPECIFICATION |
|-------------------------|------------------------------------|----------------------------------------------------|
| LENGTH | 0.448" | 0.445" +/- .005 |
| WIDTH | 0.313" | 0.313" +/- .003 |
| THICKNESS | 0.0102" | 0.010" +/- .0003 |
| BEVEL | 11 TO 12.5 DEG | 11.5 Deg +/- 1 Deg |
| MOUNTING
HOLE LENGTH | 0.2805 | 0.2805 +/-.0005 |
| MOUNTING
HOLE WIDTH | 0.0866 | 0.0866 +/-.0005 |
| MOUNTING
HOLE RADIUS | 0.0433 | 0.0433 +/-.0005 |
| SHARPNESS* | 4 to 7 OZ | 5.5 OZ +/- 1.5 OZ |

  • As measured in ounces of force.

At Will

(Signature)

Jonathan Woodward

(Typed Name)

November 1,.1999

K 992978 (Premarket Notification [510(k)] Number)

3

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV I 6 1999

Mr. Jonathan Woodward President Surgistar, Inc. 6068 Corte Del Cedro Carlsbad, CA 92009

Re: K992978 Trade Name: Microkeratome Blade Regulatory Class: I Product Code: 86 HNO Dated: October 13, 1999 Received: October 14, 1999

Dear Mr. Woodward:

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 .

4

Page 2 - Mr. Jonathan Woodward

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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

5

Page 2 of 5

510(k) Number (if known):__K 992978

SURGISTAR MicroKeRTome BLADE Device Name:_

Indications For Use:

Statement of indication for use

The Surgistar Microkeratome is indicated for use as a replacement blade in the Chiron Vision Automatic Corneal Shaper Surgical Instrument (ACS). The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jas Calloway
(Division Sign-Off)

Division of Ophthalmic Devices

510(k) Number K992978

Prescription Use_v (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)