(60 days)
The TyTron C-500IR Clinical Infrared Imaging System is intended for adjunctive diagnostic screening for the detection of breast cancer and other uses such as: peripheral vascular disease, neuromusculoskeletal disorders, extracranial cerebral and facial vascular disease, thyroid gland abnormalities, and various other neoplastic, metabolic, and inflammatory conditions. Use of the TyTron C-500IR System is not intended to be the sole diagnostic procedure for these diseases and conditions.
The TyTron C-500IR is a non-contact, non-invasive, non-radiating, thermal (infrared) imaging system composed of an infrared camera which is interfaced to a computer with the intent of viewing and digitally storing thermal patterns generated by the surface of the human body.
The provided text is a 510(k) premarket notification for the TyTron C-500IR Clinical Infrared Imaging System. It describes the device, its intended use, and states that it has been found "substantially equivalent" to a predicate device. However, this document does not contain information about the acceptance criteria and a detailed study proving the device meets those criteria.
Here's why and what's missing:
- Substantial Equivalence: The 510(k) process in the US largely focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This often means demonstrating similar technological characteristics and indications for use, rather than conducting new clinical trials to prove efficacy against specific, pre-defined acceptance criteria.
- Lack of Clinical Study Details: The provided text does not include any information about a clinical study, performance metrics, sample sizes, ground truth establishment, or expert involvement. The 510(k) summary typically includes general information about the device and its equivalence, but not the granular details of a performance study.
Therefore, I cannot populate the table or provide answers to most of your questions based solely on the provided text.
Based on the provided text, here's what can be stated:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided document. | Not specified in the provided document. |
Explanation: The 510(k) summary provided declares the device as "substantially equivalent" to a predicate device (Spectrum 9000MB, K020783). It does not outline specific acceptance criteria for performance within a dedicated study, nor does it report specific performance metrics for the TyTron C-500IR. The equivalence claim implies that its performance is considered acceptable due to its similarity to a device already deemed safe and effective.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. The document refers to a predicate device and a declaration of substantial equivalence, but it does not detail any specific test set data for the TyTron C-500IR.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified in the provided document.
4. Adjudication method for the test set
- Not specified in the provided document.
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
- Not specified in the provided document. The device description does not imply AI assistance, and no MRMC study details are present.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not specified in the provided document. The document describes a "Clinical Infrared Imaging System," which typically involves trained human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified in the provided document, as no specific performance study details are included.
8. The sample size for the training set
- Not specified in the provided document, as no machine learning or AI component with explicit training data is mentioned or detailed.
9. How the ground truth for the training set was established
- Not specified in the provided document, as no machine learning or AI component with explicit training data is mentioned.
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KO3247/
Titronics Research & Development Co. TyTron C-500IR CLINICAL INFRARED IMAGING SYSTEM OCT 1 0 2003 PREMARKET NOTIFICATION 510(k)
XIV. SUMMARY OF SAFETY AND EFFECTIVENESS
TyTron C-3000
| Manufacturer: | Titronics Research and Development Company2046 Redwing Hollow S.W.Oxford, IA 52322-9112 | |
|---|---|---|
| Contact Person: | Joseph Roger Titone, B.S.M.E.Same address as above | |
| Telephone:Fax: | (319) 683-2702(319) 683-2862 | |
| Date Summary Prepared: | June 14. 2003 | |
| Product Trade Name: | TyTron C-500IR Clinical Infrared Imaging System | |
| Common Name: | Clinical Thermographic Imaging System | |
| Classification: | Telethermographic system | |
| Obstetrics/Gynecology Classification Panel | ||
| 21 Code of Federal Regulations 884.2980 | ||
| Class: | I | |
| Panel: | 90 | |
| Procode: | 90 LHQ | |
| Predicate Device: | Spectrum 9000MB, submitted by TelesisTechnologies, Inc. K020783. | |
| Description: | The TyTron C-500IR is a non-contact, non-invasive,non-radiating, thermal (infrared) imaging systemcomposed of an infrared camera which is interfacedto a computer with the intent of viewing anddigitally storing thermal patterns generated by thesurface of the human body. |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 0 2003
Mr. Joseph R. Titone, BSME President Titronics Research & Develpoment Co. 2046 Redwing Hollow S.W. OXFORD IA 52322-9112
Re: K032471
Trade/Device Name: TyTron C-500IR Clincial Infrared Imaging System Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic system Regulatory Class: I Product Code: 90 LHQ Dated: August 4, 2003 Received: August 11, 2003
Dear Mr. Titone:
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 (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 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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Page 2
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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Titronics Research & Development Co. TyTron C-500IR CLINICAL INFRARED IMAGING SYSTEM PREMARKET NOTIFICATION 510(k)
IX. INDICATIONS FOR USE
The TyTron C-500IR Clinical Infrared Imaging System is intended for adjunctive diagnostic screening for the detection of breast cancer and other uses such as: peripheral vascular disease, neuromusculoskeletal disorders, extracranial cerebral and facial vascular disease, thyroid gland abnormalities, and various other neoplastic, metabolic, and inflammatory conditions. Use of the TyTron C-500IR System is not intended to be the sole diagnostic procedure for these diseases and conditions.
Prescription Use
✓
Nancy C. hogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510
510(k) Number
§ 884.2980 Telethermographic system.
(a)
Telethermographic system intended for adjunctive diagnostic screening for detection of breast cancer or other uses —(1)Identification. A telethermographic system for adjunctive diagnostic screening for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(2)
Classification. Class I (general controls).(b)
Telethermographic system intended for use alone in diagnostic screening for detection of breast cancer or other uses —(1)Identification. A telethermographic system for use as the sole diagnostic screening tool for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 884.3.