The Quantel Medical Cinescan S is intended to be used for: - the Axial Length measurement of the eye by ultrasonic means - the implanted IOL power calculation, using the Axial Length measurement. - Visualization of the interior of the eye by A and B scans.
The intended use of the Cinescan S is for diagnostic imaging of the eye by A and B scans and for biometric measurements of the eye.
The intended use of the Cinescan S 10 MHz B-scan transducer is for diagnostic imaging of the eye by B scans.
The Quantel Medical Cinescan Mhz A-scan transducer is intended to be used with the Quantel Cinescan S A-scans of the eye and for biometric measurements.
The intended use of the Cinescan S is for diagnostic imaging of the eye by B scans and for biometric measurements of the eye.

Device Description

The Cinescan S is a combined ophthalmic A and B scan system that can also be used for biometric measurements of the eye and for IOL calculations.

AI/ML Overview

The provided documentation for the "Cinescan S" Ultrasonic Ophthalmic A and B scan System (K021683) indicates that no clinical performance studies were conducted to establish acceptance criteria or to prove the device meets such criteria.

The submission explicitly states:
"Since the Cinescan uses the same technology as existing devices, clinical tests are not required."

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: No performance criteria beyond safety and efficacy equivalence to predicates are mentioned, and no specific performance metrics are reported from the Cinescan S.
Sample size used for the test set and the data provenance: No test set was used for clinical performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set was evaluated.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is an ultrasound system, not an AI diagnostic device, and no clinical studies were performed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of Device Acceptance:

The device's acceptance was based on a Special 510(k) submission which asserts substantial equivalence to legally marketed predicate devices:

"B-SCAN", K926521 (manufactured by Biovision and then B.V.I, predecessor to Quantel Medical)
Axis II, K000554 (manufactured by Quantel Medical, a modification of the "B-scan")

The justification for not requiring clinical tests was that the Cinescan S uses the "same technology as existing devices." This implies that the performance of the predicate devices implicitly serves as the "acceptance criteria" for the Cinescan S, and the direct comparison of technology is the "study" proving it meets these criteria.

Non-Clinical tests reported for the Cinescan S include:

Electrical Security (IEC 601-1)
Electromagnetic Compatibility (IEC 601-1-2)
FDA transducer emissions tests

Summary

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JUN 2 1 2002

Ko21683
1082

Special 510(k)

Cinescan S Ultrasonic Ophthalmic A and B scan System

510(k) Summary

Page :A 1 / 2

Special 510(k)

(1) Submitter information

Quantel Medical S.A.

Name :	Quantel Medical S.A.
Address:	21 rue Newton - Zone du BREZETClermont-Ferrand63039 France
Telephone:	33-473-745 745
Contact person:	Dr. George MYERS (Official Correspondent).
	Medsys Inc.377 Route 17 SouthHasbrouck Heights, New Jersey 07064Tel : 201-727-1703Fax: 201-727-1708
Date prepared :	April 10, 2002

(2) Name of Device

Trade Name:	"Cinescan S" Ophthalmic Ultrasound System
Common Name:	Ophthalmic A and B scan ultrasound system
Classification name:	System, Imaging, Ultrasonic, Ophthalmic, 980IYO

(3) Legally-marketed predicate device

The predicate devices are:

The "B-SCAN", K926521, manufactured by Biovision and then B.V.I (the predecessor company to Quantel Medical). This device included both A and B scan capability. 2. The Axis II, K000554, manufactured by Quantel Medical. This was the subject of a Special 510(k), and was also a modification of the "B-scan." A number of modifications cleared with the previous 510(k) (K000554) are also included in the Cinescan S.

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21683

Special 510(k) A.f2

Cinescan S

Ultrasonic Ophthalmic A and B scan System

510(k) Summary

Page :A 2 / 2

(4) Description

The Cinescan S is a combined ophthalmic A and B scan system that can also be used for biometric measurements of the eye and for IOL calculations.

(5) Intended Use

The Quantel Medical Cinescan S is intended to be used for :

the Axial Length measurement of the eye by ultrasonic means
the implanted IOL power calculation, using the Axial Length measurement.
Visualization of the interior of the eye by A and B scans.

(6) Performance Data

(a) Non-Clinical tests

for Electrical Security IEC 601-1 .
IEC 601-1-2 for Electromagnetic Compatibility E
FDA transducer emissions tests 赢
(b) Clinical tests

Since the Cinescan uses the same technology as existing devices, clinical tests are not required.

(7) Conclusion

The Cinescan S is equivalent in safety and efficacy to the legally-marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three overlapping human profiles facing to the right, representing health and human services. The text is in all caps and reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 1 2002

Quantel Medical S.A. % George H. Myers, Sc.D. Official Agent Medsys, Inc. 377 Route 17 South HASBROUCK HEIGHTS NJ 07604

Re: K021683

Trade Name: Cinescan S Ophthalmic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: 90 HPR and IYO Dated: May 20, 2002 Received: May 22, 2002

Dear Dr. Myers:

We have reviewed your Section 510(k) premarket 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 Cinescan S. as described in your premarket notification:

Transducer Model Number

B-scan. 10MHz STD-A A-scan, 8MHz B-HF B-scan, 20 MHz

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Myers

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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, 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free 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,

Nancy Brogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Quantel Medical

Diagnostic Ultrasound Indications for Use Form

Page 1 of of 4

510(k) Number (if known):

Device Name: Cinescan S

Intended Use: The intended use of the Cinescan S is for diagnostic imaging of the eye by A and B scans and for biometric measurements of the eye.

CLINICALAPPLICATION	A	B
Ophthamic	P	P
Fetal
Abdominal
Intra-operative(specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-rectal
Trans-vaginal
Trans-urethral
Intra-luminal
PeripheralVascular
Laparoscopic
Musculo-Skeletal
Other (Snecify)*

Mode of Operation

N= new indication; P= previously cleared by FDA; E= added under Appendix E

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) โ

Nancy C. Brandon

Division of Reprod and Radiological Dev 510(k) Number

{5}------------------------------------------------

Quantel Medical

Diagnostic Ultrasound Indications for Use Form

2 of of 4 Page

510(k) Number (if known):

Device Name: Cinescan S B-scan Transducer , 10 MHz

Intended Use: The intended use of the Cinescan S 10 MHz B-scan transducer is for diagnostic imaging of the eye by B scans..

CLINICALAPPLICATION	A	B	M	PWD	CWD	COLORDOPPLER	POWER(AMPLITUDE)DOPPLER	COLORVELOCITYIMAGING	COMBINED(SPECIFY)	OTHER(SPECIFY)
Ophthamic		E
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

N= new indication; P= previously cleared by FDA; E= added under Appendix E 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 V (Per 21 CFR 810.109)

Nancy C. Brogdon

(Division Sign-Off) Division of Reproductive. Abdon and Radiological Devi 510(k) Number

{6}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

Page 3 3 of _ 4_

510(k) Number (if known):

Device Name: Quantel Medical S.A. "STD-A" A-scan 8 MHz transducer for "Cinescan S"

Intended Use: The Quantel Medical Cinescan * Mhz A-scan transducer is intended to be used with the Quantel Cinescan S A-scans of the eye and for biometric measurements.

CLINICALAPPLICATION	A	B	M	PWD	CWD	COLORDOPPLER	POWER(AMPLITUDE)DOPPLER	COLORVELOCITYIMAGING	COMBINED(SPECIFY)	OTHER(SPECIFY)
Ophthalmic	E
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
PeripheralVascular
Laparoscopic
Musculo-Skeletal
Other (Specify)*

Mode of Operation

N= new indication; P= previously cleared by FDA; E= added under Appendix E 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,

and Radiological Devices

Nancy C Brogdon

510(k) Number	K021683
---------------	---------

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Diagnostic Ultrasound Indications for Use Form

4 Page -

510(k) Number (if known):

Device Name: Cinescan S B-scan transducer B-HF 20 MHz

Intended Use: The intended use of the Cinescan S is for diagnostic imaging of the eye by B scans and for biometric measurements of the eye.

Mode of Operation

CLINICAL	A	B	M	PWD	CWD	COLORDOPPLER	POWER(AMPLITUDE)DOPPLER	COLORVELOCITYIMAGING	COMBINED(SPECIFY)	OTHER(SPECIFY)
APPLICATION
Ophthamic		E
Fetal
Abdominal
Intra-operative(specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-rectal
Trans-vaginal
Trans-urethral
Intra-luminal
PeripheralVascular
Laparoscopic
Musculo-Skeletal
Other (Specify)*

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 810.109) Prescription Use い

Nancy C Brogdon

(Division Sign-Division of Reproductive and Radiological Device 510(k) Number

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.