(64 days)
An AC-powered slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used in the fitting of contact lenses and to aid in the diagnosis of diseases or trauma which affect the structural properties or topographic features of the anterior eye segment.
The Haag-Streit brand BC 900 slit lamp is an instrument used for eye examination and the fitting of contact lenses. The device consists of a microscope combined with a light source that can be narrowed into a slit for illumination of the eye. Each is available with accessories to measure characteristics of the eye and to document actual shapes. The device is powered by 7 to 12V AC and 50-60 Hz.
The provided document is a 510(k) summary for the Haag-Streit BC 900 Slit Lamp, a device used for eye examination. It is a pre-market notification to the FDA, asserting substantial equivalence to a predicate device. As such, the document primarily focuses on establishing this equivalence rather than presenting an extensive study with detailed acceptance criteria and performance data as one might find for a novel device or a clinical trial.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a detailed table of device performance metrics in the way a clinical study report would for a new medical device. Instead, the core "acceptance criteria" presented here revolve around the concept of substantial equivalence to a predicate device.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as stated in 510(k) Summary) |
|---|---|
| Indications for Use are Same or Similar: Device diagnoses eye conditions and aids in contact lens fitting. | "The device and accessories are indicated as a non-invasive aid in the examination and diagnosis of eye conditions and in the fitting of contact lenses. The indications are the same as those claimed for the predicate devices." (Page 0, Section 5) |
| Technological Characteristics are Same or Similar: Device operates on the same principles and has comparable features. | "The technological characteristics are the same or similar to those found with the predicate devices where the eye is examined by projecting light onto it. Additionally, standard accessories are used for tonometry, examining the vitreous and fundus of the eye and contact lens fitting as those claimed for the predicate devices." (Page 0, Section 6) |
| Safety and Effectiveness are Equivalent: By demonstrating similar indications and technological characteristics. | Implied by the claim of substantial equivalence to the predicate device (Haag-Streit brand slit lamp 9000 BM). The FDA's letter (Page 1) confirms this determination. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a test set or provide information about data provenance (e.g., country of origin, retrospective/prospective). The submission is a regulatory filing for substantial equivalence, not a report of a specific study involving a test set of data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this submission. The 510(k) process for a device like a slit lamp primarily relies on engineering and performance specifications compared to an existing predicate device, rather than a study requiring expert consensus on a dataset for ground truth.
4. Adjudication Method
This information is not applicable to this submission. There is no mention of a study involving adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this document. This type of study is more common for diagnostic imaging AI systems to evaluate the impact of AI assistance on human reader performance.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not conducted or reported. The device in question, a slit lamp, is an optical instrument requiring a human operator, not an autonomous algorithm.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied in AI/diagnostic performance studies (e.g., pathology, outcomes data) is not directly applicable here. The "ground truth" for this 510(k) submission is the functional and performance characteristics of the predicate device (Haag-Streit brand slit lamp 9000 BM), to which the BC 900 Slit Lamp is being compared for substantial equivalence. The "truth" is that the new device performs within similar parameters and for the same indications as the already legally marketed predicate.
8. Sample Size for the Training Set
This document describes a medical device (slit lamp), not an AI algorithm. Therefore, there is no concept of a "training set" as used in machine learning.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI algorithm, this point is not applicable.
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Image /page/0/Picture/0 description: The image shows the text "K982057" in a handwritten style, followed by the words "HAAG-STREIT" in a bold, sans-serif font. The handwritten text appears to be a serial number or code, while "HAAG-STREIT" likely refers to a company or brand name. The text is black against a white background, creating a high contrast image.
AUG 1 4 1998
Haaq-Streit AG Gartenstadtstrasse 10 CH-3098 Köniz / Bern
Telefon 031 971 4655 / 56 l-ax 031 971 97 73
510 (k)#: K982057
FDA, Center for Devices and Radiological Health Document Mail Centre (HFZ-401) 9200 Corporate Blvd. Rockville, Maryland 20850 / USA
UUma
Köniz, May 13, 1998
Owner/Operator ID No. 8010098 -
510 (k) Summary
This summary of 510 (k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
The submitter of this pre-market notification is: 1.
Dr. Gerd Ulbers, Director R & D Haag-Streit AG Gartenstadtstrasse 10 CH-3098 Köniz-Berne Telephone: +41 31 9714655 +41 31 9719773 Fax:
This summary was prepared on May 13, 1998.
The name of the device is the Haad-Streit BC 900 Sift Lamp. Its common name is the sit lamp 2. and the classification name is the AC-powered slit lamp biornicroscope.
- The BC 900 device is substantially equivalent to the Haad-Streit brand slit lamp 9000 BM.
The Haag-Streit brand BC 900 slit lamp is an instrument used for eye examination and the 4. fitting of contact lenses. The device consists of a microscope combined with a light source that can be narrowed into a slit for illumination of the eye. Each is available with accessories to measure characteristics of the eye and to document actual shapes. The device is powered by 7 to 12V AC and 50-60 Hz.
The device and accessories are indicated as a nonlivasive aid in the examination and 5. diagnosis of eye conditions and in the fitting of contact lenses. The indications are the same as those claimed for the predicate devices.
The technological characteristics are the same or similar to those found with the predicate 6. devices where the eye is examined by projecting light onto it. Aditionally, standard accessories are used for tonometry, examining the vitreous and tundus of the eye and contact lens filting as those claimed for the predicate devices.
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Image /page/1/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 words "DEPARTMENT OF HEALTH & HUM" on the left side and "SERVICES USA" on the top. Inside the circle is a stylized image of a bird or a symbol representing human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 4 1998
Dr. Gerd Ulbers Director, Rearch and Development Haag - Streit AG Gartenstadtstrasse 10 CH- 3098 Köniz - Berne Switzerland
Re: K982057 Trade Name: BC 900 Slit Lamp Regulatory Class: II Product Code: 86 HJO Dated: May 13, 1998 Received: June 11, 1998
Dear Dr. Ulbers:
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 (OS) 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 .
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Page 2 - Dr. Gerd Ulbers
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
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APPENDIX 3
Haaq-Streit AG Gartenstadtstrasse 10 CH-3098 Köniz / Bern
Telefon 031 9714655 / 56 Fax 031 97197 73
FDA, Center for Devices and Radiological Health Document Mail Centre (HFZ-401) 9200 Corporate Blvd. Rockville, Maryland 20850 / USA
Owner/Operator ID No. 8010098
Ul/mg
Köniz, July 24, 1998
| 510(K) Number (if known) | : Not yet allocated |
|---|---|
| Device Name | : BC 900 Slit Lamp |
4982057
Indications for Use
(Per 21 CFR 801.109)
An AC-powered slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used in the fitting of contact lenses and to aid in the diagnosis of diseases or trauma which affect the structural properties or topographic features of the anterior eye segment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Callaway
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number. K982057
Prescription Use ✓ OR Over-the-Counter Use
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.