(49 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on temperature measurement and graphical display without mentioning any analytical or interpretive functions that would typically involve AI/ML.
No
The device is described as an "adjunctive diagnostic device" that "measures and records skin surface temperatures" to aid in diagnosis, rather than to treat conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The AlfaSight 9000 is intended for the adjunct diagnosis" of various conditions. Additionally, the "Device Description" refers to it as an "adjunctive diagnostic device."
No
The device description explicitly states that the AlfaSight 9000 system consists of hardware components including a handheld probe, an off-the-shelf computer, a USB charging cable, and biocompatible sheaths. It is not solely software.
Based on the provided information, the AlfaSight 9000 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- AlfaSight 9000 Function: The AlfaSight 9000 measures and records skin surface temperatures directly on the patient's body using a handheld probe. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for the adjunct diagnosis of various conditions based on skin temperature measurements, not the analysis of biological samples.
- Device Description: The description reinforces that it's a non-invasive device that interacts directly with the skin surface.
Therefore, the AlfaSight 9000 falls under the category of a non-invasive diagnostic device that measures physiological parameters directly from the body, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AlfaSight 9000 is intended for the adjunct diagnosis of: 1) abnormalities of the female breast; 2) peripheral vascular disease; 3) musculoskeletal disorders; 4) extracranial cerebral and facial vascular disease; 5) abnormalities of the thyroid gland; and 6) various neoplastic and inflammatory conditions.
The AlfaSight 9000 is not intended to serve as a sole diagnostic screening procedure.
Product codes
LHQ
Device Description
The AlfaSight 9000 system is a non-invasive, handheld and battery-operated adjunctive diagnostic device that measures and records skin surface temperatures. The system is intended for use as an adjunct to other clinical diagnostic procedures to quantify relative skin surface temperatures. It is not intended as a sole diagnostic device and does not replace or substitute any clinical test or device such as X-Ray, CT scans, mammography or other similar equipment. The system is for prescription-only use by licensed medical practitioners for use in hospitals, sub-acute healthcare settings, and private clinics.
The AlfaSight 9000 system consists of: 1) a handheld probe, 2) an off-the-shelf computer 3) a standard USB charging cable and 4) biocompatible sheaths. The single use theath is placed over the handheld probe covering the entire probe, three capacitive pins sense contact of the skin through the sheath to start the temperature measurement. Temperature samples are then sent from the handheld probe to the computer wirelessly using Bluetooth technology and are represented in a graphical display on the computer. Samples are organized into specified regions of the body as they are sampled in a fixed order as directed by the software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared thermography
Anatomical Site
Female breast; whole body (for peripheral vascular disease; musculoskeletal disorders; extracranial cerebral and facial vascular disease; thyroid gland; and various neoplastic and inflammatory conditions)
Indicated Patient Age Range
Adult use, non pediatric
Intended User / Care Setting
licensed medical practitioners for use in hospitals, sub-acute healthcare settings, and private clinics.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The AlfaSight 9000 System has been determined through engineering to be substantially equivalent to the predicate device. Testing demonstrates that the AlfaSight 9000 conforms to ISO 10993-1, IEC 60601-1, and IEC 60601-1-2.
The following non-clinical bench performance testing has been completed for the subject device:
- Biocompatibility
- Software Risk Analysis
- Software Requirements Specification
- Software Validation Protocol
- Software Verification Summary and Test Case Report
- Software Design Specification
- Software Development Environment Description Document
- Electromagnetic Compatibility and Electrical Safety
In sum, the results of non-clinical testing demonstrate that the AlfaSight 9000 System is as safe, as effective and performs as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the outside. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 10, 2015
Alfa Thermodiagnostics, Inc. % Mr. John Smith Regulatory Counsel 555 13th Street, N.W. WASHINGTON DC 20004
Re: K150457
Trade/Device Name: AlfaSight 9000 Thermographic System Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic system Regulatory Class: I Product Code: LHO Dated: February 20, 2015 Received: February 20, 2015
Dear Mr. Smith:
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 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 (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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150457
Device Name AlfaSight 9000 Thermographic System
Indications for Use (Describe)
The AlfaSight 9000 is intended for the adjunct diagnosis of the female breast; 2) peripheral vascular disease; 3) musculoskeletal disorders; 4) extracranial cerebral and facial vascular disease; 5) abnormalities of the thyroid gland; and 6) various neoplastic and inflammatory conditions.
The AlfaSight 9000 is not intended to serve as a sole diagnostic screening procedure.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
| DATE | February 20, 2015 |
|---|---|
| SUBMITTER | Alfa Thermodiagnostics, Inc. |
| 9057 Soquel Drive, Suite B-AA | |
| Aptos, CA 95003 | |
| Tel: (831) 901-9248 | |
| Fax: (831) 685-1128 | |
| Email: drbeilin@alfathermo.com | |
| CONTACT PERSON | Daniel Beilin, O.M.D., Alfa Thermodiagnostics, Inc |
| 9057 Soquel Drive, B-AA | |
| Aptos, CA. 95003 | |
| Tel: (831) 901-9248 | |
| Fax: (831) 685-1128 | |
| Email: drbeilin@alfathermo.com | |
| DEVICE NAME | AlfaSight 9000 Thermographic System |
| Classification: | Class I |
| Common Name | Telethermographic system |
| Classification | 21 C.F.R. § 884.2980 (adjunctive use) |
| Product Code | LHQ |
| Review Panel | Obstetrics/Gynecology |
| PREDICATE DEVICE | Eidam's CRT 2000 (K971956) |
| INTENDED USE | The AlfaSight 9000 is intended for the adjunct diagnosis of: 1) abnormalities of |
| the female breast; 2) peripheral vascular disease; 3) musculoskeletal disorders; |
- extracranial cerebral and facial vascular disease; 5) abnormalities of the
thyroid gland; and 6) various neoplastic and inflammatory conditions. |
| | The AlfaSight 9000 is not intended to serve as a sole diagnostic screening
procedure. |
DEVICE DESCRIPTION
The AlfaSight 9000 system is a non-invasive, handheld and battery-operated adjunctive diagnostic device that measures and records skin surface temperatures. The system is intended for use as an adjunct to other clinical diagnostic procedures to quantify relative skin surface temperatures. It is not intended as a sole diagnostic device and does not replace or substitute any clinical test or device such as X-Ray, CT scans, mammography or other similar equipment. The system is for prescription-only use by licensed medical practitioners for use in hospitals, sub-acute healthcare settings, and private clinics.
The AlfaSight 9000 system consists of: 1) a handheld probe, 2) an off-the-shelf computer 3) a standard USB charging cable and 4) biocompatible sheaths. The single use theath is placed over the handheld probe covering the entire probe, three capacitive pins sense contact of the skin through the sheath to start the
4
temperature measurement. Temperature samples are then sent from the handheld probe to the computer wirelessly using Bluetooth technology and are represented in a graphical display on the computer. Samples are organized into specified regions of the body as they are sampled in a fixed order as directed by the software.
SUBSTANTIAL EQUIVALENCE
A comparison of the AlfaSight 9000 System's indications for use, technological characteristics, and principles of operation with the predicate device indicates that the AlfaSight 9000 system is substantially equivalent to the FDA-cleared CRT 2000 thermographic device (K971956).
The AlfaSight 9000, like the predicate device CRT-2000, is intended as an adjunct to other clinical diagnostic procedures. The indications for use are identical to the indications for the predicate CRT-2000 device.
The AlfaSight 9000 system differs from its predicate, the CRT-2000, in that it measures the skin temperature (through a biocompatible sheath) using infrared technology rather than the thermocouple measurements employed by the CRT-2000 device. The use of infrared measurements does not affect the safety or effectiveness of the AlfaSight 9000 system for its intended use, as demonstrated by the completed bench testing, including Corvalent Design Verification Testing and Temperature Probe with Sheath Performance Testing.
The points measured for the AlfaSight 9000 systems are identical to the points measured by the CRT 2000 predicate device.
| Parameter | AlfaSight 9000 | CRT 2000 (K971956) |
|---|---|---|
| Intended Use / Indications for use | Adjunct diagnosis of: |
- abnormalities of the female breast;
- peripheral vascular disease;
- musculoskeletal disorders;
- extracranial cerebral and facial vascular disease;
- abnormalities of the thyroid gland; and
- various neoplastic and inflammatory conditions.
The AlfaSight 9000 is not intended to serve as a sole diagnostic screening procedure. | Adjunct diagnosis of:
- abnormalities of the female breast;
- peripheral vascular disease;
- musculoskeletal disorders;
- extracranial cerebral and facial vascular disease;
- abnormalities of the thyroid gland; and
- various neoplastic and inflammatory conditions.
The CRT 2000 is not intended to serve as a sole diagnostic screening procedure. |
| Parameter | AlfaSight 9000 | CRT 2000 (K971956) |
| Functionality | Captures skin surface
temperatures, provides that
data in a thermographic chart
for use by the healthcare
practitioner as an adjunct to
other clinical procedures. | Captures skin surface
temperatures, provides that
data in a thermographic chart
for use by the healthcare
practitioner as an adjunct to
other clinical procedures. |
| Where used | Doctor's Office, Clinic or
Hospital | Doctor's Office, Clinic or
Hospital |
| Anatomical Sites | Same | Same |
| Target Population/ demographic | Adult use, non pediatric | Adult use, non pediatric |
| Device Regulatory Classification | 21 CFR 884.2980 | 21 CFR 884.2980 |
| Product Code | LHQ | LHQ |
| Device Class | Class I | Class I |
| Biocompatibility | (Sheath) ISO 10993-1 | Data Not Available |
| EMC and Safety | IEC 60601-1; IEC 60601-1-2 | Data Not Available |
| 510(k) number | To be determined | K971956 |
| PC Supply voltage | AC 85 -264V | AC 110 - 240 V |
| PC Power Input | 60 Watts | 180 Watt |
| PC Frequency | Hz 47-63 Hz | Hz 50/60 |
| PC Storage Temperature Range | -40°C to +85°C | 0°C - 50°C |
| PC Screen Display | Graphic LCD Display | Graphic LCD Display |
| Probe Battery | Polymer Lithium-Ion | None |
| Probe Rechargeable | Yes | N/A |
| Probe Status Indicator | Yes | Yes |
| Probe Error Margin | +/-0.2 degrees C | +/-0.2 degrees C |
| Probe Temp. Collection method | Infrared thermocouple | bi-metal thermocouple |
| Probe Skin Contact | Sheathed probe tips contact
the skin to start the
temperature measurement.
The IR sensor does not touch
the skin. | Thermocouple sensor and edge
surface of probe tip contact
the skin to take the
measurement. The sensor
touches the skin. |
| Disposable Sheath Material | Polyethylene | N/A |
| Probe Optimum Range | 25-40°C | 27-35°C |
| Probe Communication | Blue Tooth Wireless
Communication of
measurement data from Probe
to PC | Wired Communications |
| Parameter | AlfaSight 9000 | CRT 2000 (K971956) |
| Software Main functions | Receives temperature signal
and generates multiple point
temperature measurement
graphics for healthcare
practitioners on measurement
locations and temperature
measurement readings. | Receives temperature signal
and generates multiple point
temperature measurement
graphics for healthcare
practitioners on measurement
locations and temperature
measurement readings. |
| Correct Orientation and location | Measurement points are
highlighted on the figure on
the display screen for
measurement location and
sequence of measurements. | Measurement points are
highlighted on the figure on
the display screen for
measurement location and
sequence of measurements. |
The following table provides more detailed information regarding the basis for the determination of substantial equivalence:
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6
PERFORMANCE TESTING
The AlfaSight 9000 System has been determined through engineering to be substantially equivalent to the predicate device. Testing demonstrates that the AlfaSight 9000 conforms to ISO 10993-1, IEC 60601-1, and IEC 60601-1-2.
The following non-clinical bench performance testing has been completed for the subject device:
- Biocompatibility
- Software Risk Analysis
- Software Requirements Specification ●
- Software Validation Protocol
- Software Verification Summary and Test Case Report
- Software Test Results Report and Revision History in
- Software Design Specification
- Software Development Environment Description Document
- Electromagnetic Compatibility and Electrical Safety
CONCLUSION
In sum, the results of non-clinical testing demonstrate that the AlfaSight 9000 System is as safe, as effective and performs as well as the predicate device. In sum, the AlfaSight 9000 is substantially equivalent to the CRT 2000 predicate device.