(128 days)
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.
The Vacuum System primarily consists of the VCG, a vacuum pump, a tubing set with filtration, and dissectors (clockwise and counterclockwise).
The provided text does not contain detailed acceptance criteria, a structured study design, or specific performance metrics that would typically be presented in a table for a medical device. The document is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to predicate devices rather than providing an exhaustive performance study.
Here's an analysis of the information that is available, and a note on what is missing for each requested point:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated or quantified in the provided text. The document refers to "similar indications" and "similar principles of operation" and "similar technological characteristics" to predicate devices, implying that compliance with these aspects (and safety through biocompatibility and cytotoxicity) are the "criteria."
- Reported Device Performance: The document mentions that the 510(k) notice "summarizes the data regarding the use of the Vacuum System during the clinical trials of the KeraVision Intacs." However, it does not provide any specific performance data (e.g., success rates, complication rates, precision measurements, or quantitative outcomes) for the Vacuum System itself from these clinical trials. It primarily focuses on the Intacs corneal ring segments, which the Vacuum System assists in placing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Fixate the eye in patients undergoing ophthalmic surgery requiring a lamellar dissection of the cornea. (Intended Use) | The Vacuum System was used during the clinical trials of the KeraVision Intacs (corneal ring segments). (No specific performance metrics for the Vacuum System's fixation or dissection are provided, only its use in the trials.) |
| Operate on the principle of controlled vacuum to a Vacuum Centering Guide (VCG) to hold the eye for lamellar dissection and intrastromal tunnel creation. | Vacuum pump provides controlled vacuum; sterile tubing delivers vacuum; VCG holds the eye; dissectors create an intrastromal tunnel. (This describes the operation, not quantified performance.) |
| Biocompatibility with contact components. | Biocompatibility certification included. |
| Non-cytotoxic parts (VCG and dissectors). | Cytotoxicity test reports included. |
| Similar indications, principles of operation, and technological characteristics to predicate devices (Chiron Vision Corp.'s Hansatome Microkeratome, Laser Light Technology, Inc.'s Automated Disposable Disposable Keratome). | The Vacuum System and predicate devices have the same intended use and similar indications, principles of operation, and technological characteristics. Minor differences (lower max vacuum, no oscillating blade, dissects vs. cuts) do not raise new safety/effectiveness questions. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: This information is not provided. While the clinical trials for KeraVision Intacs are mentioned, no specifics on the number of patients or procedures where the Vacuum System's performance was specifically evaluated are detailed.
- Data Provenance: Not specified. It's only stated that the 510(k) "summarizes the data regarding the use of the Vacuum System during the clinical trials of the KeraVision Intacs." We do not know if these were retrospective or prospective, or the country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Ground Truth Experts: Not applicable or not provided. The device (Intacs Vacuum System) is a surgical instrument for fixation and dissection, not an interpretive diagnostic device. Therefore, a "ground truth" derived from expert consensus in the typical sense (e.g., for image interpretation) is not relevant here. The success of the device would be tied to the surgical outcome, which would be evaluated by the attending surgeon.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable or not provided. As explained above, this isn't a diagnostic device requiring adjudicated interpretation. Surgical outcomes would typically be confirmed by the operating surgeon and follow-up examinations by ophthalmologists.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This device is a surgical instrument, not an AI-assisted diagnostic tool. Therefore, an MRMC study and effects on human reader performance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a manual surgical instrument that assists human surgeons, not an automated algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The closest concept to "ground truth" for this device would be the successful completion of the lamellar dissection and creation of the intrastromal tunnel, and ultimately, the clinical outcome of the Intacs procedure (e.g., corneal ring segment placement, refractive correction). This would fall under outcomes data as observed and recorded by the operating surgeon and subsequent ophthalmological examinations during the KeraVision Intacs clinical trials.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is not a machine learning or AI device that requires a training set in the conventional sense. The "training" for such mechanical devices typically involves engineering design, prototyping, and bench testing, followed by clinical trials.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. As this is not an AI/ML device, a "training set" and associated ground truth for it are not relevant concepts in this context.
{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)
§ 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.