(156 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard ultrasonic A-scan technology for biometric measurements and IOL calculations, without mentioning any AI/ML components or algorithms.
No.
The device is used for diagnostic measurements (biometric measurement of the eye, IOL power calculation) and does not provide any therapeutic intervention.
Yes
The device is used for "biometric measurement of the eye," specifically "Axial Length measurement" and "Implanted IOL power calculation." While it doesn't diagnose a disease directly, it provides quantitative measurements that are critical inputs for medical decisions and the planning of treatments related to eye conditions (e.g., cataract surgery planning), fitting the definition of aiding in diagnosis or treatment planning.
No
The device description explicitly states it is an "ultrasonic system" composed of a laptop computer, an acquisition module, and A-scan probes. This includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The QUANTEL MEDICAL AXIS NANO Ophthalmic Ultrasound System performs in vivo measurements. It uses ultrasound to measure the axial length of the eye directly on the patient's body.
- Lack of Sample Analysis: The device does not analyze samples taken from the body.
Therefore, while it is a diagnostic device, it falls under the category of in vivo diagnostic devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The QUANTEL MEDICAL AXIS NANO Ophthalmic Ultrasound System and the probes that are used with it are indicated for the biometric measurement of the eye including:
- Axial Length measurement of the eye by ultrasonic means.
- Implanted IOL power calculation, using the Axial Length measurement. .
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX
Device Description
The AXIS NANO is an ultrasonic system designed for ophthalmic use. It uses A type scaris for biometric measurements of the eye. The system is composed of a laptop computer connected an acquisition module. The A-scan probe (either TP-01-b or TP-02-las) connects to the acquisition module.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Eye
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory testing following the guidance "Information for manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound systems and Transducers" (Sept 9, 2008) was conducted to verify that the AXIS NANO met design specifications and was substantially equivalent to the predicate devices. No Clinical testing is required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K094038 Quantel Medical Compact TOUCH Ophthalmic Ultrasound System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Section 5
8102027 DEC 2 2 2010
510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.87 and 807.92. Summary preparation date 06-04-10 [21 CFR 807.92(a)(1)].
Applicant Name and Address [21 CFR 807.92(a)(1)] A.
Quantel Medical S.A.
21 rue Newton
ZI Le Brezet
63039 Clermont Ferrand Cedex 2
FRANCE
Tel: +33 (0) 473 745 745
Fax: +33 (0) 473 745 700
B. Contact Information
Quantel USA
601 Haggerty Lane
Bozeman, MT 59715
Tel: 406-586-0131
Fax: 406-586-2924
Contact person: Michael Johnson M.D.
1
Device Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] C.
Trade Name: AXIS NANO Ophthalmic Biometer Ultrasound System
Device Common Name: Ophthalmic Ultrasound System
Classification Name: System, Imaging, Ultrasonic, Ophthalmic (per 21 CFR 892.1560)
Product Code: IYO
Panel: Ophthalmology
Device Classification: Class II
Predicate Devices [21 CFR 807.92(a)(3)] D.
The AXIS NANO uses similar technology and physical output characteristics as the following predicate devices:
K094038 Quantel Medical Compact TOUCH Ophthalmic Ultrasound System
Device Description [21 CFR 807.92(a)(4)] E.
The AXIS NANO is an ultrasonic system designed for ophthalmic use. It uses A type scaris for biometric measurements of the eye. The system is composed of a laptop computer connected an acquisition module. The A-scan probe (either TP-01-b or TP-02-las) connects to the acquisition module.
Device Specifications [21 CFR 807.92(a)(6)] F.
The AXIS NANO system includes an A-scan ultrasonic probe. The A-scan probe (TP-01 / TP-02-las) operates at 11 MHz and has an effective diameter of 5 mm. This probe is identical to that used by the predicate, Compact TOUCH cleared under K094038.
2
G.
Indications for Use [21 CFR 807.92(a)(5)]
The QUANTEL MEDICAL AXIS NANO Ophthalmic Ultrasound System and the probes that are used with it are indicated for the biometric measurement of the eye including:
- Axial Length measurement of the eye by ultrasonic means.
- Implanted IOL power calculation, using the Axial Length measurement. .
H. Performance Data [21 CFR 807.92(b)(2)]
Laboratory testing following the guidance "Information for manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound systems and Transducers" (Sept 9, 2008) was conducted to verify that the AXIS NANO met design specifications and was substantially equivalent to the predicate devices. No Clinical testing is required.
I. Conclusion [21 CFR 807.92(b)(3)]
Technologically, the AXIS NANO was found to be substantially equivalent to the currently cleared K094038 Quantel Medical Compact TOUCH Ophthalmic Ultrasound System. The AXIS NANO has only a subset of functionality that the Compact TOUCH has, specifically it only connects to the A-scan transducer and only does biometric measurements. It lacks the B-scan and Pachymetry functions of the Compact TOUCH. The indications for use are similar to the previously cleared device. The risks and benefits for the AXIS NANO are argued to be comparable to the predicate devices. We believe that there are no new questions of safety or efficacy raised by the introduction of the AXIS NANO.
3
Image /page/3/Picture/14 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, representing movement or progress. The text "DEPARTMENT OF HEALTH" is vertically oriented and positioned to the left of the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Quantel Medical S.A. % Michael Johnson, M.D. Medical Product Manager Quantel USA 601 Haggerty Lane BOZEMAN MT 59715
DEC 2 2 2010
Re: K102027
Trade/Device Name: AXIS NANO with Quantel Medical Transducer for Biometery Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: November 2, 2010 Received: November 5, 2010
Dear Dr. Johnson:
We have reviewed your Section 510(k) premarket 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 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). 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.
This determination of substantial equivalence applies to the following transducers intended for use with the AXIS NANO with Quantel Medical Transducer for Biometery, as described in your premarket notification:
Transducer Model Number
TP-01-b / TP-02-las
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
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.
This letter will allow you to begin marketing your device as described in your 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 market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.
Sincerely yours,
Dneth Kffl
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
5
Section 4
Indications for Use
510(k) Number (if known): NA
DEC 2 2 2010
Device Name:
Indications for Use:
The QUANTEL MEDICAL AXIS NANO Ophthalmic Ultrasound System and the probes that are used with it are indicated for the biometric measurement of the eye including:
- Axial Length measurement of the eye by ultrasonic means.
- Implanted IOL power calculation, using the Axial Length measurement. .
4-1
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 810.109)
Division Sign Off
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K102027
6
Diagnostic Ultrasound Indications for Use Form
2 of Page
510(k) Number (if known): NA
Device Name: AXIS NANO with Quantel Medical Transducer for Biometry (Ref: TP-01-b / TP-02-las).
Intended Use:
The QUANTEL MEDICAL AXIS NANO Ophthalmic Ultrasound System and the probes that are used with it are indicated for the biometric measurement of the eye including:
- Axial Length measurement of the eye by ultrasonic means. -
- Implanted IOL power calculation, using the Axial Length measurement. .
| CLINICAL
APPLICATION | A | B | M | PWD | CWD | COLOR
DOPPLER | POWER
(AMPLITUDE)
DOPPLER | COLOR
VELOCITY
IMAGING | COMBINED
(SPECIFY) | OTHER
(SPECIFY) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | P | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Peripheral | | | | | | | | | | |
| Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | | |
| Other (Specify)* | | | | | | | | | | |
Mode of Operation
| Other (Specify)"
N= new indication; P= previously cleared by FDA; E=added under Appendix E N= new nutcation, F= proviously cleared by PP-01-b / TP-02-las were previously cleared in K094038.
4-2 (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 810.109)
Signature
(Division Sign-Of Division of Radiological De Vitro Diagnostic Device Evalua Office of In
510K K10227