Pocket III

{0}------------------------------------------------ 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). {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K232302 Device Name Pocket III #### Indications for Use (Describe) 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. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | <span style="text-decoration: underline;"><b></b></span> | | | <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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 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. {4}------------------------------------------------ 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 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. ## 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 thickness<br>measurement | Corneal thickness<br>measurement | | Indications for Use | The Pocket III is intended<br>to be used for the<br>measurement of corneal<br>thickness by ultrasonic<br>means. | The Quantel Medical<br>Pocket Ultrasonic<br>Pachymeter is intended to<br>be used for the<br>measurement of corneal<br>thickness by ultrasonic<br>means, which is required<br>for some types of corneal<br>surgery. | | Clearance Type | Prescription | Prescription | | Technology | Ultrasound | Ultrasound | | Application | Ophthalmic pachymeter | Ophthalmic pachymeter | | Patient contacting<br>material | Polystyrene (Rexolite<br>1422) | Polystyrene (Rexolite<br>1422) | | 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 {5}------------------------------------------------ | | Doughty<br>Dresdner | Doughty<br>Dresdner | |-------------------|------------------------------------------------------------------------------|-------------------------------------------------------------------------| | Power | 3.7 V Lithium Ion battery<br>and external AC/DC wall<br>mount adapter 5V 10W | Battery, external power<br>supply | | 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 surface<br>device, intact skin, limited<br>duration | Per ISO 10993-1 for<br>surface device, intact skin,<br>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 {6}------------------------------------------------ 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.