(15 days)
ATP is intended to measure intra-ocular pressure and comeal thickness of the eye for the purpose of aiding in the diagnosis and monitoring of glaucoma.
Not Found
The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) premarket notification letter from the FDA regarding the "ATP (Auto Non-Contact) Tonometer/Pachymeter)" and an "Indications for Use Form" for a diagnostic ultrasound.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance
- Sample sizes and data provenance for the test set
- Number and qualifications of experts for ground truth establishment
- Adjudication method
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study
- Results of a standalone performance study
- Type of ground truth used
- Sample size for the training set
- Method for establishing ground truth for the training set
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, which is the symbol of HHS. The image is in black and white.
Public Health Service
OCT 2 8 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Reichert, Inc. % Mr. N. E. Devine Responsible Third Party Official Entela, Inc. 3033 Madison Ave., SE GRAND RAPIDS MI 49548
Re: K042831
Trade/Device Name: ATP (Auto Non-Contact) Tonometer/Pachymeter) Regulation Number: 21 CFR 892.1560 and 886.1930 Regulation Name : Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: 90 IYO and 86 HKX Dated: October 12, 2004 Received: October 13, 2004
Dear Mr. Devine:
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 (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 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 docs 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.
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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 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrb/dsmaldsmamain.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. srogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer
Indended Use: ATP is intended to measure intra-ocular pressure and comeal thickness of the eye for the purpose of aiding in the diagnosis and monitoring of glaucoma.
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDopplier | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | P | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Interoperative (specify) | ||||||||||
| Interoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transcrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletol Conventional | ||||||||||
| Musculo-skeletol Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: The above indications for use is for the ATP with the (13861-401)
detachable probes.
510k) N
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Elaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K042831
A3-7
Prescription Use
.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.