(31 days)
Not Found
No
The summary describes a mechanical microkeratome and explicitly states that no AI, DNN, or ML was mentioned. Performance studies were not required due to similarity to predicate devices, further indicating a lack of complex algorithmic components.
No.
The device is used to resect a flap of tissue, which is a surgical procedure, not a therapeutic treatment.
No
Explanation: The device is described as a microkeratome indicated for the "resection of a circular anterior lamellar flap," which is a surgical procedure, not a diagnostic one.
No
The device description explicitly states it is a "microkeratome that rotates at 14,000 rpm," indicating a physical, mechanical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The INNOVATOME™ microkeratome is a surgical instrument used to physically resect a lamellar flap from the cornea. It operates mechanically to cut tissue.
- Lack of Diagnostic Testing: The description does not mention any analysis of biological samples or the detection of diseases or conditions through testing.
The device is a surgical tool used for a specific procedure on the eye, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The INNOVATOME™ microkeratome is indicted for the resection of a circular anterior lamellar flap.
Product codes (comma separated list FDA assigned to the subject device)
86 HNO, 86 HMY
Device Description
The INNOVATOME™ is a microkeratome that rotates at 14,000 rpm and is capable of creating lamella with diameters ranging from 8-10 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
None. The specifications and intended uses of the INNOVATOME™ Microkeratome are the same as or very similar to those of the claimed predicate devices, e.g., the Chiron Microkeratome and the Plancon Microlamellar Keratome. Because of this, performance data were not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Chiron Microkeratome (K941550), Plancon Microlamellar Keratome (as described in K960395 and K970377), unnamed microkeratome cited in K960395
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K913294/A'
510(K) Summary INNOVATOME™ MICROKERATOME
OCT - 3 1997
This 510(K) summary of safety and effectiveness for the INNOVATOME™ Microkeratorne is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(K) summary.
Innovative Optics, Inc
| Address: | 4307 Cedarwood Drive
Lilburn, GA 30247 |
|---------------------------------------|-------------------------------------------------------------------|
| Contact Person: | Mr. Larry Hicks
President |
| Telephone: | 770-717-0707
770-717-9386 - Fax |
| Preparation date:
(of the summary) | August 1997 |
| Device Trade Name: | INNOVATOMET™ Microkeratome |
| Common Name | Microkeratome |
| Classification Name: | Keratome Surgical Instrument :
Ophthalmology (21 CFR 886.4370) |
| Class of Device: | Class I (AC powered or Battery powered) |
| Legally marketed predicate device: | Chiron Microkeratome: Plancon Microlame
Keratome |
Description of the Device:
Intended use:
Applicant:
ar
The INNOVATOME™ is a microkeratome that rotates at 14,000 rpm and is capable of creating lamella with diameters ranging from 8-10 mm.
The INNOVATOME™ microkeratome is indicted for the resection of a circular anterior lamellar flap.
This intended uses is the same or similar to that for the claimed predicate device.
1
Comparison_of the InnovaTome™ and The rotational speed, the depth of cut to create a lamella, and the diameters legally marketed of the resulting lamellae are essentially predicate devices: the same for these devices.
There are no significant differences between these devices under conditions of intended use.
I NNOVATOME™ its INDICATIONS : The and claimed predicates have the same indication; i.e., used to create corneal lamellae, i.e., corneal resection.
-
Performance Data: None. The specifications and intended uses
of the INNOVATOME™ Microkeratome are the same as or very similar to those of the claimed predicate devices, e.g., the Chiron Microkeratome and the Plancon Microlamellar Keratome.
Because of this, performance data were not required. -
CONCLUSION : Based on the foregoing, Innovative, Optics,
Inc. believes that the INNOVATOME™ microkeratome is substantially equivalent to the claimed legally marketed predicate devices, i.e. . . the Chiron Microkeratome and the Plancon Microlamellar Keratome.
2
COMPARISON TO PREDICATE DEVICES
Comparison of specifications of INNOVATOME™ Microkeratome and claimed predicate devices:
| Specification | INNOVATOMETM
Microkeratome | Chiron Microkeratome* | Plancon Microlamellar
Microkeratome** |
|-----------------------------------------|---------------------------------------|--------------------------|------------------------------------------|
| Keratome Material
Blade | Stainless Steel
Sapphire | Stainless Steel
Steel | Stainless Steel
Stainless Steel |
| Keratome | adjustable | adjustable | adjustable |
| Rotational Speed
Usual or recommend. | 12,000 rpm; 24,000
cuts per minute | 14,000 rpm | 0 - 20,000 rpm
14,000 rpm |
| Diameter of lamella | 8-10 mm | 9.5-10.0 mm | not stated* |
| Thickness of lamella | 175 microns | 130-180 microns | not stated* |
| Indications | see below | see below | see below |
a brochure covering the Chiron Microkeratome is attached *** for reference
copy of Safety and Effectiveness Summary for K960395 is * attached for reference - this document cites unnamed predicate devices
INDICATIONS
The INNOVATOME" microkeratome INNOVATOME™ Microkeratome: indicated for is anterior lamellar circular resection. Chiron Microkeratome: Lamellar circular resection Plancon Microlamellar Kerat.: Microlamellar keratoplasty
- None. The specifications and intended uses
of the INNOVATOME™ microkeratome are the same Performance Data: very similar to those of the claimed or predicate devices, e.g., the Chiron the Plancon microlamellar microkeratome, keratome, and an unnamed device cited in K960395 (see attached document).
are no significant differences There in specifications of the cited devices or of intended use.
Because of this, performance data were not required.
3
CONCLUSION : Based on the foregoing, Innovative Optics,
Inc. believes that the INNOVATOME" microkeratome is substantially equivalent to the claimed legally marketed predicate devices such as the Chiron microkeratome (K941550), the Plancon Microlamellar keratome (as described in K960395 and K970377), or the unnamed microkeratome cited in K960395.
Attachment 1 - Chiron Brochure (page 6 in this application) Attachment 2 - Public summary for K960395 (pages 7-8 in this application
4
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is facing to the right. The text is in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 3 1997
Mr. Larry Hicks President Innovative Optics, Inc. 4307 Cedarwood Drive Lilburn, GA 30247
Re: K973294 Trade Name: Innovatome™ Microkeratome Regulatory Class: I Product Codes: 86 HNO and 86 HMY Dated: September 2, 1997 Received: September 2, 1997
Dear Mr. Hicks:
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 - Mr. Larry Hicks
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your devices, 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
ATTACHMENT D
INDICATIONS FOR USE STATEMENT
510(K) Number (if known): _________________________________ .. x
INNOVATOME™ MICROKERATOME Device Name:
Indications For Use:
The INNOVATOME™ microkeratome system is indicated for the resection of a circulal anterior lamellar flap.
Note: The device is labeled as a restricted device (21 CFR 801.109) - see Operator's Manual
(PLEASE DO NOT MRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 810.109) OR
9
Over-The-Counter-Use
Denis L. M° Carthy