(255 days)
Not Found
No
The device description and performance studies focus on standard ultrasonic measurement technology and validation against existing devices, with no mention of AI or ML.
No
The device is used for measurement and diagnostic purposes (corneal thickness) to pre-plan surgery, not for direct treatment or therapy.
Yes
The device is described as an "Ultrasonic Pachymeter" intended for "measurement of corneal thickness." While it doesn't explicitly state it diagnoses a disease, the measurement of corneal thickness is a key part of diagnosing and planning treatment for various ocular conditions, particularly those requiring "corneal surgery." The information it provides is directly used to understand and manage a patient's condition, which aligns with the function of a diagnostic device.
No
The device description explicitly states it is a "small, hand-held ultrasonic Ophthalmic Pachymeter" and uses "pulsed ultrasound" to measure corneal thickness, indicating it is a hardware device that utilizes software for processing and presentation of results.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Quantel Medical POCKET Ultrasonic Pachymeter directly measures the thickness of the cornea in vivo (within the living body) using ultrasound. It does not analyze samples taken from the body.
- Intended Use: The intended use is for measuring corneal thickness for surgical planning, which is a direct measurement on the patient, not an analysis of a biological sample.
Therefore, based on its function and intended use, this device falls under the category of a medical device used for direct measurement on a patient, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The device is intended to be used for the measurement of corneal thickness by The device is mich is required for some types of corneal surgery.
The Quantel Medical POCKET Ultrasonic Pachymeter is intended to be used for the measurement of corneal thickness, which is required for some types of corneal surgery.
Product codes (comma separated list FDA assigned to the subject device)
90 IYO
Device Description
The POCKET is a small, hand-held ultrasonic Ophthalmic Pachymeter that uses the principles of sonar (pulsed ultrasound) to measure corneal thickness. The device allows the operator to pre-plan a series of measurements on the surface of the cornea, to go automatically from one to the other while making the measurements, and then to present the results of the measurements as thickness over an area of the eye.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic
Anatomical Site
Cornea
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)
(a) Non-clinical tests The POCKET has passed all tests for IEC 601-1 and 601-1-2. The unit has also had accuracy tests done by an outside laboratory. Transducers have had output emissions done by an outside laboratory. The Pocket software has undergone extensive validation testing.
(b) Clinical tests Since the POCKET uses the same technology as existing devices, clinical tests are Billed in I OCREF assos and in Europe for several years and has not had reported problems.
(c) Conclusions The Pocket pachymeter is equivalent in safety and efficacy to the legallymarketed predicate devices.
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.
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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K993674
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Ouantel Medical S.A.. 510(k) Submission "Pocket" Ultrasonic Pachymeter
510(k) Summary
(1) Submitter Information
Name: Quantel Medical S.A.
Address: 89, Boulevard Etienne Clémentel 63100 Clermont-Ferrand FRANCE
Telephone Number: +33 (0) 473-25-62-27
Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone 201-727-1703 Fax 201-727-1708
Date Prepared: October 26, 1999
(2) Name of Device
Trade Name: "Pocket" Ultrasonic Pachymeter Common Name: Ultrasonic Pachymeter for Measurement of Corneal thickness Classification name: System, Imaging, Ultrasonic, Ophthalmic, 9801YO
(3) Equivalent legally-marketed devices.
(4) Description
The POCKET is a small, hand-held ultrasonic Ophthalmic Pachymeter that uses the principles of sonar (pulsed ultrasound) to measure corneal thickness. The device allows the operator to pre-plan a series of measurements on the surface of the cornea, to go automatically from one to the other while making the
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K993674
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measurements, and then to present the results of the measurements as thickness over an area of the eye.
- (5) Intended Use
The device is intended to be used for the measurement of corneal thickness by The device is mich is required for some types of corneal surgery.
(6) Performance Data
. (a) Non-clinical tests
The POCKET has passed all tests for IEC 601-1 and 601-1-2. The unit has also had accuracy tests done by an outside laboratory.
Transducers have had output emissions done by an outside laboratory.
The Pocket software has undergone extensive validation testing.
(b) Clinical tests
Since the POCKET uses the same technology as existing devices, clinical tests are Billed in I OCREF assos and in Europe for several years and has not had reported problems.
(c) Conclusions
The Pocket pachymeter is equivalent in safety and efficacy to the legallymarketed predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
JUL 1 3 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Quantel Medical S.A. c/o George H. Myers, Sc.D. Official Correspondent Medsys, Inc. 377 Route 17 South Hasbrouck Heights, NJ 07604
K993674 Re : Quantel Pocket Ultrasonic Pachymeter Regulatory Class: II/21 CFR 892.1560 Product Code: 90 IYO Dated: June 16, 2000 Received: June 19, 2000
Dear Dr. Myers:
We have reviewed your Section 510(k) 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 Quantel Packet Ultrasonic Pachymeter, as described in your premarket notification:
Transducer Model Number
P1 (20 MHz A-Scan)
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - George H. Myers, Sc.D.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Other general information on your responsibilities under the Act may 807.97). be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" .
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Daniel C. Sezom
Daniel G. Schultz, M.D.
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Quantel Medical
Diagnostic Ultrasound Indications for Use Form
Page
510(k) Number (if known):
Device Name: Quantel Medical S.A. ''Pocket'' Pachymeter
Intended Use: The Quantel Medical POCKET Ultrasonic Pachymeter is intended to be Intended Use: The Qualitel Mcdical I OCRET Offically of the some types of corneal surgery.
| CLINICAL
APPLICATION | A | B | M | PWD | CWD | COLOR
DOPPLER | POWER
(AMPLITUDE)
DOPPLER | COLOR
VELOCITY
IMAGING | COMBINED
(SPECIFY) | OTHER
(SPECIFY) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | N | | | | | | | | | |
| 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
Additional Comments:
(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) | |
|---|---|---|
| ------------------ | --------------- | ---------------------- |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K993674 |
|---|---|
| --------------- | --------- |
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