(128 days)
Not Found
Not Found
No
The summary describes a mechanical vacuum system and surgical tools, with no mention of AI, ML, image processing, or data-driven decision-making.
Yes
The device is described as being used in ophthalmic surgery to fixate the eye and dissect the lamellae for the placement of corneal ring segments to treat myopia, which is a therapeutic intervention.
No
The device is described as being used to fixate the eye and dissect the lamellae to create tunnels for placement of corneal ring segments during ophthalmic surgery. This is a surgical tool, not a device used to diagnose a condition.
No
The device description explicitly lists hardware components such as a vacuum pump, tubing set, and dissectors, indicating it is not solely software.
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 used to "fixate the eye in patients undergoing ophthalmic surgery requiring a lamellar dissection of the cornea" and to "fixate the eye and dissect the lamellae to create tunnels for placement of corneal ring segments to treat myopia." This describes a surgical device used directly on the patient's eye, not a device used to examine specimens (like blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information.
- Device Description: The components listed (vacuum pump, tubing, dissectors) are consistent with a surgical instrument, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, providing diagnostic results, or any of the typical characteristics of an IVD.
Therefore, the KeraVision® Intacs™ Vacuum System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The KeraVision® Intacs™ Vacuum System ("the Vacuum System") is intended to be used to fixate the eye in patients undergoing ophthalmic surgery requiring a lamellar dissection of the cornea.
The KeraVision Intacs™ Vacuum System is indicated to fixate the eye and dissect the lamellae to create tunnels for placement of corneal ring segments to treat myopia.
Product codes
HNO
Device Description
The Vacuum System primarily consists of the VCG, a vacuum pump, a tubing set with filtration, and dissectors (clockwise and counterclockwise).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cornea / eye
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)
A biocompatibility certification regarding the contact components of the device is included in the 510(k) notice. In addition, the 510(k) notice includes cytotoxicity test reports regarding the VCG and the dissectors. The 510(k) notice also summarizes the data regarding the use of the Vacuum System during the clinical trials of the KeraVision Intacs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Chiron Vision Corp.'s Hansatome Microkeratome, Laser Light Technology, Inc.'s Automated Disposable Keratome ("ADK")
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
4/28/99
510(k) Summary for KeraVision, Inc.'s KeraVision® Intacs™ Vacuum System
Submitter's Name, Address, Telephone Number and Contact Person:
KeraVision, Inc. 48630 Milmont Drive Fremont, California, 94538
Contact: Darlene Crockett-Billig Kera Vision, Inc. Phone: (510) 353-3000 Facsimile: (510) 353-3030
Date Prepared: March 24, 1999
Name of the Device:
KeraVision® Intacs™ Vacuum System
Common or Usual Name:
Keratome
Classification Name
AC Powered Keratome
Product Code
HNO
Predicate Devices
- Chiron Vision Corp.'s Hansatome Microkeratome (1)
Laser Light Technology, Inc.'s Automated Disposable Keratome (2) ("ADK")
1
Intended Use
The KeraVision® Intacs™ Vacuum System ("the Vacuum System") is intended to be used to fixate the eye in patients undergoing ophthalmic surgery requiring a lamellar dissection of the cornea.
Principles of Operation
The vacuum pump is used to provide controlled vacuum to the Vacuum Centering Guide ("VCG"). The sterile tubing delivers vacuum from the vacuum pump to the VCG. The VCG holds the eye in position while the clockwise and counterclockwise dissectors dissect the lamellae and create an intrastromal tunnel for placement of the KeraVision® Intacs™ corneal ring segments.
Technical Characteristics
The Vacuum System primarily consists of the VCG, a vacuum pump, a tubing set with filtration, and dissectors (clockwise and counterclockwise).
Performance Data
A biocompatibility certification regarding the contact components of the device is included in the 510(k) notice. In addition, the 510(k) notice includes cytotoxicity test reports regarding the VCG and the dissectors. The 510(k) notice also summarizes the data regarding the use of the Vacuum System during the clinical trials of the KeraVision Intacs.
Summary of the Basis for the Finding of Substantial Equivalence
The KeraVision® Intacs™ Vacuum System ("the Vacuum System") and all of the predicate devices have the same intended use, i.e., fixate the eve in patients undergoing ophthalmic surgery requiring a lamellar dissection of the cornea. The Vacuum System and the predicate devices have similar indications. The Vacuum System is indicated to fixate the eye and dissect the lamellae to create tunnels for placement of corneal ring segments to treat myopia, while the predicate devices are indicated to fixate the eye and cut the lamellae for other refractive surgery procedures to treat myopia. The Vacuum System and all of the predicate devices have similar principles of operation in that vacuum pressure is supplied by a vacuum pump that secures a ring to the cornea to fixate the eye and to dissect or cut the cornea to perform refractive surgery procedures.
The Vacuum System and all of the predicate devices also have similar technological characteristics in that each of these devices has a ring, a
2
vacuum pump, a tubing set, and a surgical blade. The minor technological differences between the Vacuum System and the predicate devices are that the Vacuum System's maximum vacuum pressure is lower than the predicate devices' maximum vacuum pressure, it does not contain an oscillating blade, and it dissects and separates instead of cutting the lamellae. However, these minor technological differences do not raise any new questions of safety or effectiveness.
FDA has granted 510(k) premarket clearance to each of the predicate devices. Thus, the KeraVision® Intacs™ Vacuum System is substantially equivalent to legally marketed keratomes.
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 image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the central image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 1999
KeraVision, Inc. Mr. Howard H. Holstein c/o Hogan & Hartson, LLP 555 13th Street, N.W. Washington, DC 20004-1109
Re: K984540
Trade Name: Keravision® Intacs™ Vacuum System Regulatory Class: I Product Code: 86 HNO Dated: March 24, 1999 Received: March 24, 1999
Dear Mr. Holstein:
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 OS 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. Howard H. Holstein
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
510(k) Number (if known):__K984540
Device Name: Intacs™ Vacuum System
Indications for Use:
The KeraVision Intacs™Vacuum System is indicated to fixate the eye and dissect the lamellae to create tunnels for placement of corneal ring segments to treat myopia.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Quynh Hoang, scientific Reviewer
(Division Sign-Off) Division of Ophthalmic Devices K984540 510(k) Number _
Prescription Use _X (Per 21 C.F.R. 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)