(85 days)
Summit Technology K-B Microkeratome K980675
Not Found
No
The summary does not mention AI, ML, image processing, or any data related to training or testing AI/ML models. The device description is also not available.
No
Explanation: The device is intended to perform penetrating cuts of the central portion of the cornea for corneal transplantation, which is a surgical procedure, not a therapeutic treatment.
No
The device is described as performing "penetrating cuts of the central portion of the cornea" for "corneal transplantation," which indicates a surgical or treatment purpose, not a diagnostic one.
No
The device is described as an "Automated Trephine System" intended to perform "penetrating cuts of the central portion of the cornea." This strongly implies a physical device that interacts with the cornea, not solely software. The predicate device is also a microkeratome, which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for performing penetrating cuts of the cornea for corneal transplantation. This is a surgical procedure performed directly on a patient's body.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not involve the examination of specimens.
- Anatomical Site: The device operates on the cornea, which is part of the living body, not a specimen taken from the body.
Therefore, the ASMOTOM Automated Trephine System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ASMOTOM Automated Trephine System is intended to perform penetrating cuts of the central portion of the cornea. The Primary and only purpose of this device is to produce cuts necessary for the corneal transplantation.
The ASMOTOM Automated Trephine System is intended to perform penetrating cuts of the central portion of the cornea. The purpose of this device is to produce cuts necessary for the corneal transplantation.
Product codes (comma separated list FDA assigned to the subject device)
HRG
Device Description
Not Found
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): 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.
Summit Technology K-B Microkeratome K980675
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
§ 886.4070 Powered corneal burr.
(a)
Identification. A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye.(b)
Classification. Class I (general 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.
0
DEC 1 4 2001
K013151 510(K) SUMMARY
(as required by 807.92(c))
| Submitter of 510(k): | BKG Opthalmics USA, Inc.
7334 Hollister Ave., Suite I
Goleta, CA 93117 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone:
Fax: | 805-685-9991
805-685-1292 |
| Contact Person: | Les Vorosmarthy |
| Date of Summary: | October 29, 2001 |
| Trade Name: | ASMOTOM Automated Trephine System |
| Classification Name: | Trephine, AC-Powered |
| Product Code: | HRG |
| Regulation Number: | 886.4070 |
| Predicate Device: | Summit Technology K-B Microkeratome K980675 |
| Intended Use: | The ASMOTOM Automated Trephine System is intended
to perform penetrating cuts of the central portion of the
cornea. The Primary and only purpose of this device is to
produce cuts necessary for the corneal transplantation. |
:
1
Device Comparison Chart
| Feature | BKG Ophthalmic
ASMOTOM | Summit K-B
Microkeratome |
|--------------------------------|-----------------------------------------|-----------------------------------------------------------|
| Indications for
Use | Keratoplasty | Same |
| Method of cut | Automatic - to preset
depth | Automatic - Step
motor controlled 0.1
to 3.0mm/sec. |
| Materials
(Patient Contact) | Stainless Steel and Brass | Stainless Steel,
Plastic, Glass,
Natural Diamond |
| Blade Oscillation | Adjustable, Patient
preset available | Adjustable, with
preset default |
| Manufacturer | Deutschmann -
Medizintechnik | Gebauer GMBH |
| Motor | 12 V | 12 V |
| Speed | 16,500 RPM | 5,000 - 20,000 RPM |
| Weight | 200 g | N/A |
| Power Supply | 90 V - 240 V | 100 V - 240 V |
| Frequency | 50 - 60 Hz | Same |
| Vacuum | 0 - 800 mbar | 0 - 1.0 bar |
| Suction Rings | Yes | Yes |
| Blades | 6.0 mm - 8.2 mm | Various |
| Off-Set Rings | 0.2 mm - 1.2 mm | Programmable |
| Hand Switch | Yes | Yes |
| Foot Switch | Yes | Yes |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2001
BKG Opthalmics USA, Inc. c/o Mr. Arthur Ward, Consultant 962 Allegro Lane Apollo Beach, FL 33572
Re: K013151
Trade/Device Name: ASMOTOM Automated Trephine System Regulation Number: 21 CFR 886.4070 Regulation Name: Trephine, AC-Powered Regulatory Class: I Product Code: HRG Dated: November 9, 2001 Received: November 13, 2001
Dear Mr. Ward:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally prematicate 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known): _
ASMOTOM Automated Trephine System Device Name:
Indications For Use:
The ASMOTOM Automated Trephine System is intended to perform penetrating cuts of the The ASMOTON of the cornea. The purpose of this device is to produce cuts necessary for the corneal transplantation.
(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) (Optional Format 1-2-96)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Dinas L. "C. Carter
(Division Sign-Off) Division of Ophthalmic Devices 101315 510(k) Number.