(140 days)
Not Found
No
The summary describes a mechanical microkeratome and makes no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The device is indicated for "lamellar resection of the cornea," which is a surgical procedure performed to treat or correct a medical condition, thereby making it a therapeutic device.
No
Explanation: The device is described as an instrument for "lamellar resection of the cornea" and "cutting a precise corneal disc." This indicates a surgical or therapeutic function, not a diagnostic one. There is no mention of it being used to identify or analyze a condition.
No
The device description explicitly states it is a "precision-manufactured instrument" designed for cutting, which indicates a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "lamellar resection of the cornea." This is a surgical procedure performed on a living patient, not a test performed on a sample taken from the body.
- Device Description: The device is described as a "precision-manufactured instrument designed for cutting a precise corneal disc." This is a surgical tool, not a device used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is clearly a surgical instrument used directly on the patient's cornea.
N/A
Intended Use / Indications for Use
The SIS, Ltd., ACCM microkeratome is a precision-manufactured instrument indicated for lamellar resection of the cornea.
Product codes
86 HNO
Device Description
The SIS, Ltd ACCM Microkeratome is a precision-manufactured instrument designed for cutting a precise corneal disc of preselected thickness and diameter. The design, material and operating principle are very similar to those of the predicate devices.
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
The ACCM microkeratome has been designed and tested to applicable safety standards. Parameters related to lamellar resection were validated through extensive preclinical testing. The ACCM microkeratome does not raise any new issues of safety, effectiveness, or performance of the product.
Key Metrics
Not Found
Predicate Device(s)
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
FEB 1 0 2000
SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Submitter's name, address, telephone number, contact person, and date summary 1. prepared:
- Surgical Instrument Services (SIS), Ltd. a. P. O. Box CH-2501 Biel Switzerland Phone: 41 (32) 332-91 61 41 (32) 332-91 62 Fax:
- b. Contact Person: Frank Ziemer Managing Director, New Product Development
- Date Summary Prepared: January 28, 2000 c.
Name of device, including trade name and classification name: 2.
- Trade/Proprietary Name: Keratome a.
- Classification Name: Keratome b.
Identification of the predicate device or legally marketed device or devices to which 3. substantial equivalence is being claimed:
| Company: | Bausch & Lomb Surgical |
|---|---|
| Device: | Hansatome Microkeratome |
| 510(k) : | K972808 |
| Date Cleared: | October 24, 1997 |
| Company: | Bausch & Lomb Surgical |
| Device: | Advance Corneal Shaper - ACS |
| 510(k) : | K913697 |
| Date Cleared: | November 5, 1991 |
1
4. A description of the device that is the subject of the 510(k), including explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):
The SIS, Ltd ACCM Microkeratome is a precision-manufactured instrument designed for cutting a precise corneal disc of preselected thickness and diameter. The design, material and operating principle are very similar to those of the predicate devices.
ട. Statement of intended use:
The SIS, Ltd. ACCM Microkeratome is indicated for lamellar resection of the cornea.
2
Statement of how the technological characteristics of the device compare to those 6. of the predicate or legally marketed device.
Surgical Instrument Systems Advanced Computer Controlled Microkeratome
TABLE 1 TECHNOLOGICAL COMPARISON
| CHARACTERISTICS | SIS-ACCM | Predicate Device
Automatic Corneal Shaper | Predicate Device
Hansatome Microkeratome |
|----------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------|
| Intended Use | Lamellar Corneal Resections | Lamellar Corneal Resections | Lamellar Corneal Resections |
| Operating Principle | Electrically driven oscillating blade | Electrically driven oscillating blade | Electrically driven oscillating blade |
| Suction Ring | Interchangeable heads with fixed
thickness plates | One head with interchangeable
thickness plates | Interchangeable heads with fixed
thickness plates |
| Blade Drive Source | Electric Motor 6-9V DC
(Reusable) | Electric Motor 12V DC (Reusable) | Electric Motor 6-9V DC
(Reusable) |
| Thickness Control | Fixed thickness plate in blade holder;
two blade holders available | Thickness Plates | Thickness Plates |
| Blade Speed | Blade Oscillation 8000 RPM. | Blade Oscillation 7,500 RPM | Blade Oscillation >7,500 RPM |
| Blade Angle | 25° | 25° | Unknown |
| Blade Material | Low carbon stainless steel -
Disposable, Single-Use | Low carbon stainless steel -
Disposable, Single-Use | Low carbon stainless steel -
Disposable, Single Use |
| Blade Sterilization Method | Gamma irradiation | Gamma irradiation | EtO |
| Flap Diameter | 8.5 mm and 9.5 mm | 9.0 mm | 10 mm |
| Flap Thickness Options | 160µm and 180 µm | 160µm and 180 µm | 160µm and 180 µm |
| Hinge Location | Nasal or superior | Nasal | Superior |
| Keratome Mechanism | Dual rectilinear guide rails which are
symmetrical. | Dual linear guideways with single
linear gear track | Single arcuate gear rack with temporal
pivot pin |
| Console Details | | | |
| Electrical | 110V or 215V AC | 110V or 215V AC | 110V or 215V AC |
| Vacuum Pump | AC Powered | AC Powered | AC Powered |
| Blade Height Verification | Clinically measured with microscope.
Quality control check in house concerning mounting | Clinically measured with microscope. | Clinically measured with microscope. |
| Foot Controls | DC Powered | DC Powered | DC Powered |
3
7. Brief summary of nonclinical tests and results:
The ACCM microkeratome has been designed and tested to applicable safety standards. Parameters related to lamellar resection were validated through extensive preclinical testing. The ACCM microkeratome does not raise any new issues of safety, effectiveness, or performance of the product.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure with three flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 2000
Ms. Judy Gordon Regulatory Consultant to S.I.S. ClingReg Consulting Services, Inc. 18732 Saginaw Irvine, CA 92612
Re: K993190 Trade Name: Advanced Computer Controlled Microkeratome (ACCM) Regulatory Class: I Product Code: 86 HNO Regulation: 886.4370 (Keratome) Dated: January 13, 2000 Received: January 14, 2000
Dear Ms. Gordon:
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 .
5
Page 2 - Ms. Judy Gordon
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
6
Page of
K993190 NUMBER (IF KNOWN) : 510 (k)
Advanced Computer Controlled Microkeratome - ACCM DEVICE NAME :
INDICATIONS FOR USE:
The SIS, Ltd., ACCM microkeratome is a precision-manufactured instrument indicated for lamellar resection of the cornea.
Evenette T. Beens
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K993190
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-9