(46 days)
Not Found
No
The summary explicitly states that the device performs the same calculations and displays as the predicate device and the A-scan probe is identical. There is no mention of AI, ML, or any advanced image processing beyond standard ultrasound measurements.
No.
The device is indicated for diagnostic imaging and biometric measurement of the eye, which are diagnostic purposes, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for diagnostic imaging and biometric measurement of the eye".
No
The device description explicitly states it consists of a "base and probes," which are hardware components. The performance studies also mention hardware validation activities.
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 AXIALIS Ophthalmic Ultrasound System uses ultrasound to perform diagnostic imaging and biometric measurements directly on the eye. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "diagnostic imaging and biometric measurement of the eye," which is an in-vivo (within the living body) procedure, not in-vitro (in glass/outside the body).
Therefore, the device falls under the category of medical imaging equipment used for in-vivo diagnosis, not in-vitro diagnostics.
N/A
Intended Use / Indications for Use
The AXIALIS Ophthalmic Ultrasound System and the probes that are indicated for diagnostic imaging and biometric measurement of the eye including:
- · Axial Length measurement of the eye by ultrasonic means.
- · Implanted IOL power calculation, using the Axial Length measurement.
- · Measurement of corneal thickness by ultrasonic means.
Product codes
IYO, ITX
Device Description
The AXIALIS Ophthalmic Ultrasound System is an ultrasonic system for ophthalmology which consists of a base and probes. The base performs the same calculations and displays as the predicate device, the Quantel Medical COMPACT TOUCH. The A-scan probe for biometry and pachymetry is identical to the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonic
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)
Non-clinical testing was performed to verify that the proposed device met all design specifications and is substantially equivalent to the predicate device.
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and . A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment Part 1-2: General ● requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-6 2010, AMD 1: 2013 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Usability
- IEC 60601-2-37 Edition 2.1 2015 Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
Additionally, hardware and software validation activities were performed to ensure the device performed as intended and software documentation appropriate for the Moderate level of concern was provided.
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
§ 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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
Quantel Medical % Maureen O'Connell President O'Connell Regulatory Consultants, Inc. 44 Oak Street STONEHAM, MA 02180
November 15, 2021
Re: K213254
Trade/Device Name: AXIALIS Ophthalmic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: September 29, 2021 Received: September 30, 2021
Dear Maureen O'Connell:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213254
Device Name
AXIALIS Ophthalmic Ultrasound System
Indications for Use (Describe)
The AXIALIS Ophthalmic Ultrasound System and the probes that are indicated for diagnostic imaging and biometric measurement of the eye including:
- · Axial Length measurement of the eye by ultrasonic means.
- · Implanted IOL power calculation, using the Axial Length measurement.
- · Measurement of corneal thickness by ultrasonic means.
| 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 K213254
Quantel Medical AXIALIS Ophthalmic Ultrasound System
510(k) Owner
Quantel Medical 11 rue Bois Joli CS40015 63808 Cournon D'Auvergne-Cedex France
Submission Correspondent
Maureen O'Connell O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham, MA 02180 Phone: 978-207-1245
Date Prepared: November 4, 2021
Trade Name of Device
AXIALIS Ophthalmic Ultrasound System
Common or Usual Name
Ultrasound pulsed echo imaging system Ultrasound diagnostic transducer
Classification Name
System, Imaging, Pulse Echo, Ultrasound; 21 C.F.R. §892.1560 Class II Product Code: IYO
Transducer, Ultrasonic, Diagnostic; 21 C.F.R. §892.1570 Class II Product Code: ITX
Predicate Device(s)
Quantel Medical Compact Touch Ophthalmic Ultrasound System cleared in K180265
Device Description
The AXIALIS Ophthalmic Ultrasound System is an ultrasonic system for ophthalmology which consists of a base and probes. The base performs the same calculations and displays as the
4
predicate device, the Quantel Medical COMPACT TOUCH. The A-scan probe for biometry and pachymetry is identical to the predicate device.
Indications for Use
The AXIALIS Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including:
- Axial Length measurement of the eye by ultrasonic means. ●
- Implanted IOL power calculation, using the Axial Length measurement. ●
- Measurement of corneal thickness by ultrasonic means. ●
Substantial Equivalence
Quantel Medical believes that the AXIALIS described in this notification and for use under the conditions of the proposed labeling is substantially equivalent to a legally marketed predicate device that is a Class II medical device which is the Quantel Medical COMPACT TOUCH cleared in K180265. The intended use of both devices is diagnostic imaging and biometric measurement of the eye.
The AXIALIS has the same technological characteristics as the predicate device with the exception that the AXIALIS does not include the functionality related to the B-probe and does not include B-scan diagnostic imaging software. All other specifications and features are substantially equivalent between the AXIALIS and the COMPACT TOUCH. Therefore, the AXIALIS is substantially equivalent to the COMPACT TOUCH predicate device.
Performance Data
Non-clinical testing was performed to verify that the proposed device met all design specifications and is substantially equivalent to the predicate device.
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and . A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment Part 1-2: General ● requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-6 2010, AMD 1: 2013 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Usability
- IEC 60601-2-37 Edition 2.1 2015 Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
Additionally, hardware and software validation activities were performed to ensure the device performed as intended and software documentation appropriate for the Moderate level of concern was provided.