(269 days)
Not Found
No
The summary describes a standard ultrasonic pachymeter that measures corneal thickness based on the time it takes for ultrasonic pulses to return. There is no mention of AI, ML, or any advanced processing beyond basic signal acquisition and numerical display. The performance studies focus on accuracy against test blocks and software verification, not on the performance of any learning algorithm.
No.
The device is used for measurement and diagnosis, not for treating a condition or disease.
Yes
The device measures corneal thickness, which is a diagnostic measurement used by healthcare professionals in clinical applications to assess the eye. The output (numerical measurement) provides information that is used to inform a diagnosis or guide treatment.
No
The device description explicitly states it is a "small hand-held device in pen-shaped design" with an "integrated 30 MHz pachymetry probe" and an "ultrasonic transducer," indicating it is a hardware device that uses ultrasonic technology for measurement.
Based on the provided information, the Pocket III is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Pocket III directly measures the corneal thickness of a patient using ultrasound. It does not analyze a sample taken from the body.
- The intended use is for direct measurement on a living patient. The description clearly states it's used for "measurement of corneal thickness by ultrasonic means with pachymetry" and the device "makes contact with, and transmits ultrasonic pulses through, the surface cornea."
The Pocket III is a medical device used for diagnostic purposes, but it falls under the category of in vivo diagnostic devices, as it performs measurements directly on the patient's body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
IYO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic Pulsed Echo Imaging System
Anatomical Site
Cornea (Ophthalmology)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
This device should be operated by doctors or other appropriately-trained healthcare professionals and should be used in health institutions.
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.
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: +/- 5 microns
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.
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.
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) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 | |
| 510 (K) Number | - | K993674 |
| Intended Use | Corneal thickness | |
| measurement | Corneal thickness | |
| measurement | ||
| Indications for Use | The Pocket III is intended | |
| to be used for the | ||
| measurement of corneal | ||
| thickness by ultrasonic | ||
| means. | The Quantel Medical | |
| Pocket Ultrasonic | ||
| Pachymeter is intended to | ||
| be used for the | ||
| measurement of corneal | ||
| thickness by ultrasonic | ||
| means, which is required | ||
| for some types of corneal | ||
| surgery. | ||
| Clearance Type | Prescription | Prescription |
| Technology | Ultrasound | Ultrasound |
| Application | Ophthalmic pachymeter | Ophthalmic pachymeter |
| Patient contacting | ||
| material | Polystyrene (Rexolite |
-
| Polystyrene (Rexolite -
|
| 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 |