(77 days)
The intended use of the ODM-2100 & ODM-2200 includes the location and visualization of ophthalmic disorders and measurement of ocular distances.
Ultrasound Imaging of the eye.
Axial biometric parameter measurement of the eye.
Diagnostic ultrasound imaging
The ODM-2100/2200 combines a B-scanner used for the visualization by ultrasound of the eye and orbit and an A-scan used for intraocular measurements. The intended used of this system includes the localization and visualization of ophthalmic disorders and measurement of the eye and orbit.
The ODM-2200 uses the same software and hardware (Switch power supply, P.C. board, user's interface, transducer etc.) as ODM-2100 does. The only difference is that:
ODM-2100 uses a portable housing and built-in 10-inch video monitor; ODM-2200 uses standard SVGA. LCD monitor.
The ODM-2100/2200 includes B-mode ultrasonic cross-section imaging and A-mode axial biometric parameter measurement. Users can switch between these two modes through keyboard.
In B-mode, the 10MHz transducer emits ultrasound under electric pulse and then receives and stores its echo reflected by interfaces of different tissues. Through the sector scanning of transducer, several echo lines create real time image of eye tissue and the image is displayed on the monitor.
In A-mode, the 10MHz transducer transmits ultrasound into eye tissue and receives its echo reflected back by anterior chamber, lens and vitreum. Each length and their sum (AL) are calculated by measuring the time spent in different parts.
The provided 510(k) summary for the MEDA. Co., Ltd. ODM-2100/2200 Ultrasonic A/B Scanner for Ophthalmology indicates that no clinical tests were required or performed for the device. Therefore, no acceptance criteria based on clinical performance or a study demonstrating the device meets such criteria can be extracted from this document.
The summary states:
"2) Clinical test: Not required"
Instead of clinical testing, the device's equivalence in safety and efficacy to a legally marketed predicate device (Sonomed Medical E-Z Scan™ AB5500*, K040668) was established through non-clinical tests. These non-clinical tests focused on compliance with safety, electromagnetic compatibility (EMC), acoustic output, and biological safety standards.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving clinical performance, as the submission explicitly states that such clinical testing was not required for this 510(k) clearance.
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MEDA. CO., LTD
510(k) Premarket Notifica Model ODM-2100/2200 Ultrasonic A/B Scanner For Ophthalmology
Attachment 8 510(K) Summary
510(k) SUMMARY
JAN 2 9 2007
1) Submitter Infortation
Name: MEDA. Co., Ltd. Address: Room D, F3, Building C2, Xinmao Science Skill Park, Huayuan Industry Development Area, Tianjin, China
Phone: 86-22-83713808 Fax: 86-22-83713880
Contact person: Edward A. Kroll Spectre Solutions, Inc. 5905 Fawn Lane Cleveland, Ohio 44141 Phone: (440) 546-9810 Fax: (440) 546-9124
Data Prepared: July 10, 2006
2) Name of Device
Trade Name: ODM-2100 Ultrasonic A/B Scanner for Ophthalmology ODM-2200 Ultrasonic A/B Scanner for Ophthalmology Common Name: Ultrasonic A and B Scan System for Ophthalmology Classification Name: Ultrasonic Pulsed Echo Imaging System Regulation Number: 892.1560 Product Code: 90-IYO
3) Predicate Devices
Sonomed Medical E-Z Scan™ AB5500*, K040668
4) Intended Use
The intended use of the ODM-2100 & ODM-2200 includes the location and visualization of ophthalmic disorders and measurement of ocular distances.
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5) Device Description
The ODM-2100/2200 combines a B-scanner used for the visualization by ultrasound of the eye and orbit and an A-scan used for intraocular measurements. The intended used of this system includes the localization and visualization of ophthalmic disorders and measurement of the eye and orbit.
The ODM-2200 uses the same software and hardware (Switch power supply, P.C. board, user's interface, transducer etc.) as ODM-2100 does. The only difference is that:
ODM-2100 uses a portable housing and built-in 10-inch video monitor; ODM-2200 uses standard SVGA. LCD monitor.
6) Technological characteristics
a) Devices Description
The ODM-2100/2200 includes B-mode ultrasonic cross-section imaging and A-mode axial biometric parameter measurement. Users can switch between these two modes through keyboard.
In B-mode, the 10MHz transducer emits ultrasound under electric pulse and then receives and stores its echo reflected by interfaces of different tissues. Through the sector scanning of transducer, several echo lines create real time image of eye tissue and the image is displayed on the monitor.
In A-mode, the 10MHz transducer transmits ultrasound into eye tissue and receives its echo reflected back by anterior chamber, lens and vitreum. Each length and their sum (AL) are calculated by measuring the time spent in different parts.
b) Performance Data
-
- Non-clinical test
Compliance Tests for ODM-2100 are as follows: Safety Test (IEC 60601-1, Tested by TÜV) EMC Test Report (IEC 60601-1-2, Tested by TÜV) Acoustic output Test (FDA Guidance Document "Information for Manufacture Seeking Marketing Clearance of Diagnostic Ultrasound System and Transducers") Biological Safety Test (ISO 10993, Tested by TÜV)
- Non-clinical test
- Clinical test: Not required
3) Conclusions
The ODM-2100/2200 Ultrasonic A/B Scanner for Ophthalmology is equivalent in safety and efficacy to the legally marketed predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines extending from its lower body, resembling a flag or banner.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Meda. Ltd. % Mr. Edward A. Kroll President Spectre Solutions, Inc. 5905 Fawn Lane CLEVELAND OH 44141
JAN 2 9 2007
Re: K063433
Trade Name: Model ODM 2100 and 2200 Ultrasonic A/B Scanner for Ophthalmology Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYO and ITX Dated: November 8, 2006 Received: December 5, 2006
Dear Mr. Kroll:
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 Model ODM 2100 and 2200 Ultrasonic A/B Scanner for Ophthalmology, as described in your premarket notification:
Transducer Model Number
A-Scan (10MHz) B-Scan (10MHz)
Image /page/2/Picture/13 description: The image is a circular seal with the letters "FDA" in a stylized font in the center. Below the letters, the word "Centennial" is written in a cursive font. Above the letters, the numbers "12X - XX" are written. The seal is surrounded by a circular border with text that is difficult to read due to the image quality.
ling Public . 1
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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.
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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
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If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D. at (240) 276-3666.
V
Sincerely yours,
David W. Logeman
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{5}------------------------------------------------
Indications for Use
100 K063433 510(k) Number (if known):
Device Name: Model ODM 2100 and 2200 Ultrasonic A/B Scanner for Ophthalmology
Indications for Use:
- Ultrasound Imaging of the eye .
- Axial biometric parameter measurement of the eye .
Prescription Use X (Part 21 CFR 801 Subpart D)
-
- 12
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
1 - 1 - 1 - 1 -
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Geluidh. Segner
Division Sign Off
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Pelvic Devices
K063433
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Attachment 1
Ko63433
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
System: ODM-2100/2200 Ultrasonic A/B Scanner for Ophthalmology Transducer:
Intended Use: Diagnostic ultrasound imaging
| Clinical Application | Mode Of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other*(Specify) | |
| Ophthalmic | N | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (Specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neuonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardicac | ||||||||||
| Transesophageal | ||||||||||
| transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Contents:
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
Gavin A. Segrem
Diff. V
Reproductive, Abdominal,
Various
Page l
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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM Kob3433
ODM-2100/2200 Ultrasonic A/B Scanner for Ophthalmology System: Transducer: __ A-Scan (10MHz)
Intended Use: Diagnostic ultrasound imaging
| Clinical Application | Mode Of Operation | Combined(specify) | Other*(Specify) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | ||||
| Ophthalmic | N | ||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (Specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neuonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Contents:
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
David G. Ingram
(Division Sign-Off) Division of Reproductive, Abdomi and Radinlogical Devices 50 g. Sumber _________________________________________________________________________________________________________________________________________________________________
Page 2
§ 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.