(69 days)
No
The device description explicitly states that the AT 030 works solely mechanically and there are no mentions of AI, DNN, or ML.
No.
The device is for measuring intraocular pressure, which aids in diagnosis and management of glaucoma, but it does not treat or cure the condition itself.
Yes
The device measures intraocular pressure, and this measurement contributes to the diagnosis and management of glaucoma.
No
The device description explicitly states that the AT 030 consists of physical components like a measuring prism, rotary knob, and graduated drum, and that it works "solely mechanically." It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The AT 030 is an applanation tonometer that directly measures intraocular pressure by contacting the patient's cornea. It does not examine specimens derived from the human body.
- Intended Use: The intended use is to measure intraocular pressure, which is a physical measurement taken directly from the patient's eye, not from a biological sample.
Therefore, based on the provided information and the definition of an IVD, the AT 030 is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AT 030 is an appliance that serves to measure intraocular pressure, according to the Goldman method. Assessment of IOP may contribute to the diagnosis, and aid in the management of glaucoma.
Product codes
HKY
Device Description
The AT 030 applanation tonometer serves for measuring intraocular pressure, following the principle introduced by Professor Goldmann.
The AT 030 consists of the applanation tonometer with a measuring prism. The measuring prism, which includes a built-in optical doubling system, can be attached to the tonometer via the extensible measuring prism holder. The prism contacts the patient's cornea and the applanation surface is observed through the stereomicroscope of the slit lamps. The rotary knob of the graduated drum allows the user to vary the applied force. A scale on the tonometer indicates a value that can be converted into the intraocular pressure by using the conversion table supplied in the Instruction for Use.
The AT 030 applanation tonometer is compatible with the following ZEISS slit lamps: SL 120 (K133476), SL 130 (K133476), SL 220 (K162684), LSL VISULAS 532s (K013402), and LSL VISULAS 532s vite (K100035). The AT 030 works solely mechanically.
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
Bench Testing: The AT 030 has been tested and shown to comply with the applicable requirements of ANSI Z 80.10-2014 Ophthalmic Instruments - Tonometers. The AT 030 meets the requirements of a reference tonometer as specified in Annex A of ANSI Z80.10.
Key Metrics
Measurement Range: 2 – 80 mm Hg
Accuracy and repeatability: The measurement deviation in the measuring prism is in the measuring range from 0 – 58.84 mN and amounts to a maximum of ±1.5% and to a minimum of ±0.49 mN of the nominal value
Predicate Device(s)
Reference Device(s)
K133476, K162684, K013402, K100035
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.1930 Tonometer and accessories.
(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".
June 7, 2018
Carl Zeiss Meditec AG % Becky Ditty Consultant Biologics Consulting 1555 King Street, Suite 300 Alexandria, Virginia 22314
Re: K180839
Trade/Device Name: AT 030 Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and Accessories Regulatory Class: Class II Product Code: HKY Dated: March 30, 2018 Received: March 30, 2018
Dear Becky Ditty:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Denise L. Hampton -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180839
Device Name AT 030 Applanation Tonometer
Indications for Use (Describe)
The AT 030 is an appliance that serves to measure intraocular pressure, according to the Goldman method. Assessment of IOP may contribute to the diagnosis, and aid in the management of glaucoma.
Type of Use (Select one or both, as applicable)
| ☒ Transaction (For CA-CPRA/VCDPA Purposes) | ☐ Opt-Out/Consent (If Applicable) |
|---|---|
| -------------------------------------------------------------------------------------------- | ----------------------------------- |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for AT 030 is provided below.
SUBMITTER 1.
| Applicant: | Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
D-07745 Jena
Germany
Tel: +49 3641 220 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dr. Christian Münster
Director Regulatory and Clinical Affairs
+49 7364 20 6985
Christian.Muenster@zeiss.com |
| Submission Correspondent: | Becky Ditty
Consultant
Biologics Consulting
1555 King Street, Suite 300
Alexandria, VA 22314
bditty@biologicsconsulting.com
Phone: (269) 888-2516 |
June 4, 2018 Date Prepared:
2. DEVICE
| Device Trade Name: | AT 030 |
|---|---|
| Device Common Name: | Applanation tonometer |
| Classification Name: | 21 CFR 886.1930 - Tonometer and Accessories |
| Regulatory Class: | II |
| Product Code: | HKY |
PREDICATE DEVICES 3.
Predicate Device: Haag-Streit Goldmann manual tonometer (AT 900. Models R, t, BQ): K981432
4
4. DEVICE DESCRIPTION
The AT 030 applanation tonometer serves for measuring intraocular pressure, following the principle introduced by Professor Goldmann.
The AT 030 consists of the applanation tonometer with a measuring prism. The measuring prism, which includes a built-in optical doubling system, can be attached to the tonometer via the extensible measuring prism holder. The prism contacts the patient's cornea and the applanation surface is observed through the stereomicroscope of the slit lamps. The rotary knob of the graduated drum allows the user to vary the applied force. A scale on the tonometer indicates a value that can be converted into the intraocular pressure by using the conversion table supplied in the Instruction for Use.
The AT 030 applanation tonometer is compatible with the following ZEISS slit lamps: SL 120 (K133476), SL 130 (K133476), SL 220 (K162684), LSL VISULAS 532s (K013402), and LSL VISULAS 532s vite (K100035). The AT 030 works solely mechanically.
5. RISK MANAGEMENT
Risk management is ensured via a risk analysis, which is used to identify potential hazards and mitigations. These potential hazards are controlled by design means, protection measures and user instructions. To confirm that the measures are effective and that the device meets its intended use, verification of requirements and standards was performed. Carl Zeiss Meditec adheres to recognized and established industry practice and relevant international standards where indicated.
INDICATIONS FOR USE 6.
The AT 030 is an appliance that serves to measure intraocular pressure, according to the Goldman method. Assessment of IOP may contribute to the diagnosis, and aid in the management of glaucoma.
5
TECHNOLOGICAL COMPARISON 7.
The essential characteristics are shown within the below table.
| SUBJECT DEVICE | PREDICATE DEVICE | |
|---|---|---|
| FEATURE | AT 030 | GOLDMANN MANUAL |
| TONOMETER | ||
| AT 900 / HAAG-STREIT AG | ||
| (K981432) | ||
| Operation principle | Goldmann Tonometer | Goldmann Tonometer |
| Type | Manual contact tonometer | Manual contact tonometer |
| Indication | Intraocular Pressure (IOP) | |
| measurement | Intraocular Pressure (IOP) | |
| measurement | ||
| Type of Pressure Transducer | Measuring Prism | Measuring Prism |
| Measuring Prism | Article#: HSC 1000855 | |
| Identical / unmodified | Article#: HSC 1000855 | |
| Cleared in K981432 | ||
| Prism Material | Acrylic (PMMA) | Acrylic (PMMA) |
| Measurement technique | The measuring of the pressure | |
| requires to maintain a uniform | ||
| applanation of the surface of | ||
| the cornea. | The measuring of the pressure | |
| requires to maintain a uniform | ||
| applanation of the surface of | ||
| the cornea. | ||
| Applanation surface diameter | 3.06 mm | 3.06 mm |
| Measurement Range | 2 – 80 mm Hg | 0 – 80 mm Hg |
| Measurement reading | reading the value | |
| multiplying x 10 | ||
| yields the IOP in mm Hg | reading of the value, | |
| multiplying x 10 | ||
| yields the IOP in mm Hg | ||
| Accuracy and repeatability | The measurement deviation in | |
| the measuring prism is in the | ||
| measuring range from | ||
| 0 – 58.84 mN and amounts to a | ||
| maximum of ±1.5% | ||
| and to a minimum of ±0.49 mN | ||
| of the nominal value | The measurement deviation in | |
| the measuring prism is in the | ||
| measuring range from | ||
| 0 - 58.84 mN and amounts to a | ||
| maximum of ±1.5% | ||
| and to a minimum of ±0.49 mN | ||
| of the nominal value |
6
8. PERFORMANCE DATA
Biocompatibility Testing
The AT 030 is a surface contacting device intended for limited contact with intact corneas. The device is intended for limited contact duration. The AT 030 is identical in patient contacting materials as the predicate device, therefore no new biocompatibility testing is necessary.
Sterilization
The AT 030 is used non-sterile and sterilization is not applicable. Service life, cleaning and disinfection process is identical to the predicate device.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing is not applicable. AT 030 does not contain electrical components.
Software
Software verification and validation is not applicable. The AT 030 device does not include software.
Bench Testing
The AT 030 has been tested and shown to comply with the applicable requirements of ANSI Z 80.10-2014 Ophthalmic Instruments - Tonometers. The AT 030 meets the requirements of a reference tonometer as specified in Annex A of ANSI Z80.10.
Animal Testing
Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.
Clinical Data
Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device.
CONCLUSION 9.
AT 030 has the same intended use and technological characteristics as the predicate device AT 900 manufactured by Haag-Streit AG (K981432).
The differences in technological characteristics does not raise new questions of safety and effectiveness. ZEISS believes that the subject device AT 030 is substantially equivalent to the predicate device.