The Pocket III is intended to be used in ophthalmology clinical applications for measurement of corneal thickness by ultrasonic means with pachymetry. This device should be operated by doctors or other appropriately-trained healthcare professionals and should be used in health institutions. The device is not intended for fetal use.

Device Description

The Pocket III is a small hand-held device in pen-shaped design. Measurement results appear numerically on the LCD graphic display. The user can perform a basic cable transfer (USB-C) or activate Bluetooth to export data to a computer. The Pocket III is equipped with an integrated 30 MHz pachymetry probe. The ultrasonic transducer makes contact with, and transmits ultrasonic pulses through, the surface cornea. Echoes are returned from the anterior and posterior surfaces of the cornea.

AI/ML Overview

Acceptance Criteria and Device Performance Study for Quantel Medical Pocket III

Here's an analysis of the provided information regarding the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Accuracy	+/- 5 microns
Resolution	1 micron
Corneal thickness range	150-1200 microns
Ultrasonic Transducer Frequency	30 MHz
Tip Diameter	1.2 mm
Focal Point	0.5 mm from tip
Angle	35 degrees
Thermal Index	<1
Electrical Safety	Complies with IEC 60601-1
EMC (Electromagnetic Compatibility)	Complies with IEC 60601-1-2
Usability	Complies with IEC 60601-1-6
Ultrasound Safety	Complies with IEC 60601-2-37
Battery Safety	Complies with IEC 62133-2 Ed. 1.0 2017
Biocompatibility	Complies with ISO 10993-1 for surface device, intact skin, limited duration
Software Performance	Performs as intended, appropriate for Moderate level of concern

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Pachymetry measurements recorded with test blocks were verified for all available freeze acquisition measuring modes (Easy, Medium and Hard) from 208 um to 1042 um of theoretical value of test block."

Sample Size for Test Set: Not explicitly stated as a number of individual measurements or "patients." The testing involved "test blocks" covering a range of corneal thickness values (208 µm to 1042 µm). The number of individual measurements taken on these blocks is not specified.
Data Provenance: The data is from non-clinical testing using "test blocks." This indicates an in-vitro or simulated environment, not human subject data. Therefore, there is no country of origin or retrospective/prospective status as it is not derived from human patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable. The ground truth for the test set (the "theoretical value of test block") appears to be based on the known, calibrated values of the test blocks themselves, rather than expert interpretation of patient data.
Qualifications of Experts: Not applicable, as expert consensus was not used to establish the ground truth for these test blocks.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. As the ground truth was based on the known theoretical values of the test blocks, there was no need for expert adjudication. The device's measurements were directly compared to these known values.

5. Was a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Done?

No, an MRMC comparative effectiveness study was not done. The document describes non-clinical testing focused on the device's technical specifications and accuracy against test blocks, not a comparison of human reader performance with and without AI assistance.

6. Was a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Done?

Yes, in essence, a standalone performance evaluation was done for the device's core pachymetry function. The statement "Pachymetry measurements recorded with test blocks were verified... all results are acceptable and compliant with an accuracy of ±5μm" describes the device (algorithm and hardware) operating independently to produce a measurement, which was then compared to a known standard (the test block). While it's a physical device rather than purely an algorithm, the evaluation focuses on its direct output accuracy.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth used was based on the known, theoretical values of calibrated test blocks.

8. The Sample Size for the Training Set

Sample Size for Training Set: The document does not provide information regarding a training set. This is not a machine learning or AI device that typically requires a large training dataset for its primary function of ultrasonic pachymetry measurement. The device's operation relies on established physical principles of ultrasound.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As no training set information is provided, the method for establishing its ground truth is also not mentioned.

Summary

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April 26, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Quantel Medical % Maureen O'connell President O'Connell Regulatory Consultants, Inc. 44 Oak Street STONEHAM MA 02180

Re: K232302

Trade/Device Name: Pocket III Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO Dated: March 27, 2024 Received: March 27, 2024

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements. the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-reportmedical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Yanna S. Kang -S

Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K232302

Device Name Pocket III

Indications for Use (Describe)

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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K232302

510(k) SUMMARY

Quantel Medical Pocket III

510(k) Owner

Quantel Medical 1 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: April 19, 2024

Trade Name of Device Pocket III

Common or Usual Name

Ultrasonic Imaging System

Classification Name

System, Imaging, Pulsed Echo, Ultrasonic

Product Codes: IYO

Device Classification Class II 21 C.F.R. §892.1560

Predicate Device(s) Quantel Medical Pocket Ultrasonic Pachymeter cleared in K993674

Device Description

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The Pocket III is equipped with an integrated 30 MHz pachymetry probe. The ultrasonic transducer makes contact with, and transmits ultrasonic pulses through, the surface cornea. Echoes are returned from the anterior and posterior surfaces of the cornea.

Indications for Use

Substantial Equivalence

Quantel Medical believes that the Pocket III 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. The following is a tabular presentation of the Pocket III compared with the predicate device which is the Quantel Medical Pocket Ultrasonic Pachymeter cleared in K993674.

Manufacturer	QUANTEL MEDICAL	QUANTEL MEDICAL
Model	Pocket III	Pocket
510 (K) Number	-	K993674
Intended Use	Corneal thicknessmeasurement	Corneal thicknessmeasurement
Indications for Use	The Pocket III is intendedto be used for themeasurement of cornealthickness by ultrasonicmeans.	The Quantel MedicalPocket UltrasonicPachymeter is intended tobe used for themeasurement of cornealthickness by ultrasonicmeans, which is requiredfor some types of cornealsurgery.
Clearance Type	Prescription	Prescription
Technology	Ultrasound	Ultrasound
Application	Ophthalmic pachymeter	Ophthalmic pachymeter
Patient contactingmaterial	Polystyrene (Rexolite1422)	Polystyrene (Rexolite1422)
Probe reference	P2	P1
Type	A	A
Transducer Frequency	30 MHz	20 MHz
Tip Diameter	1.2 mm	1.2 mm
Resolution	1 micron	1 micron
Accuracy	+/- 5 microns	+/- 5 microns
Focal point	0.5 mm from tip	0.5 to 2 mm from tip
Angle	35 degrees	45 degrees
Thermal Index	<1	<1
Corneal thickness range	150-1200 microns	200-1300 microns
IOP Formula	Ehlers	Ehlers

Pocket III Substantial Equivalence

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	DoughtyDresdner	DoughtyDresdner
Power	3.7 V Lithium Ion batteryand external AC/DC wallmount adapter 5V 10W	Battery, external powersupply
Electrical Safety	Per IEC 60601-1	Per IEC 60601-1
EMC	Per IEC 60601-1-2	Per IEC 60601-1-2
Biocompatibility	Per ISO 10993-1 for surfacedevice, intact skin, limitedduration	Per ISO 10993-1 forsurface device, intact skin,limited duration
Ultrasound Safety	Per IEC 60601-2-37	Per IEC 60601-2-37

The intended use of the Pocket III is the same as the intended use of the predicate device and the indications for use are also nearly identical. Both devices are prescription devices for use by trained healthcare providers. The Pocket III has the same technological characteristics as the predicate device as described in the table above. Both devices are ophthalmic ultrasonic pachymeters for measurement of corneal thickness. The specifications for both devices are similar and both devices comply with IEC 60601-2-37. Both are powered by a power supply or a battery. Both devices meet electrical safety and EMC standards and both are made from the same biocompatible patient contacting materials. Both devices use the same three formulae for correction of a measurement in accordance with IOP. Therefore, the Pocket III is substantially equivalent to the 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.

AAMI ANSI ES60601-1 Medical electrical equipment-Part 1: General requirements for ● basic safety and essential performance
IEC 60601-1-2 Medical electrical equipment-Part 1-2: General requirements for basic ● safety and essential performance-Collateral standard: Electromagnetic compatibility-Requirements and tests
. IEC 60601-1-6 Medical electrical equipment-Part 1-6: General requirements for safety-Collateral Standard Usability
. IEC 60601-2-37 Medical electrical equipment-Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
IEC 62133-2 Edition 1.0 2017 Secondary cells and batteries containing alkaline or other non-acid electrolysis-Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications-Part 2: Lithium systems.

Pachymetry measurements recorded with test blocks were verified for all available freeze acquisition measuring modes (Easy, Medium and Hard) from 208 um to 1042 um of theoretical

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value of test block. After measurements, all results are acceptable and compliant with an accuracy of ±5μm.

Additionally, software verification and validation activities were performed to ensure the device performed as intended and software documentation appropriate for the Moderate level of concern was provided.

In conclusion, non-clinical testing supports substantial equivalence to the predicate device.

Regulation Number and Section

§ 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.