(18 days)
Not Found
No
The description focuses on traditional ultrasound technology and measurement techniques, with no mention of AI or ML.
No
The device is used for measurement and calculation (diagnosis/planning), not for directly treating a disease or condition.
No
The device is described as a biometer that measures the axial length, anterior chamber depth, and lens thickness of the eye, and calculates IOL power. While these measurements are crucial for surgical planning, the device itself is not described as diagnosing a disease or condition. It provides quantitative measurements rather than a diagnostic interpretation.
No
The device description explicitly states it "utilizes an eye-contact probe to generate and receive the ultrasound pulses," indicating a hardware component is essential to its function.
Based on the provided information, 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 (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body.
- Device Function: The AccuSonic A-Scan device directly measures structures within the eye using ultrasound. It does not analyze specimens taken from the body.
- Intended Use: The intended use is to measure ocular structures and calculate IOL power, which are procedures performed directly on the patient.
Therefore, the AccuSonic A-Scan is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The instrument is used for measuring the axial length, anterior chamber depth and lens thickness of the eye. It is also used for calculating the optical power of the IOL to be implanted during cataract surgery.
Product codes (comma separated list FDA assigned to the subject device)
IYO
Device Description
The AccuSonic A-Scan device is designed as a biometer, which uses pulsed echo ultrasound to measure the axial length, and the location of other structures of the eye. It utilizes an eye-contact probe to generate and receive the ultrasound pulses, and provides a one-dimensional display of returning pulse echoes, with positive peaks to indicate the location of ocular structures. The distance between peaks can be measured.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
pulsed echo ultrasound
Anatomical Site
eye
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)
Not Found
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.
K960765, K860757, K903666, K872726, K913067
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
OCT 1 0 2003
510(k) SUMMARY AccuSonic A-Scan
| Applicant: | Accutome Inc. |
|---|---|
| Address: | 263 Great Valley Parkway |
| Malvern, PA 19355 | |
| Contact Person: | Jeffrey L. Wright |
| Manager, Engineering, Manufacturing & QC | |
| Telephone: | (610) 889-0200 |
| (610) 889-3233 fax | |
| Preparation Date: | August 25, 2003 |
| Device Name: | AccuSonic A-Scan |
| Common Name: | Biometer |
| Classification: | System, Imaging, Pulsed Echo, Ultrasonic |
| (see: 21 CFR 892.1560) Product Code: IYO Panel: 90 | |
| Legally Marketed | |
| Predicate Devices: | Accutome Advent AB (K960765) previously by Mentor |
| Ophthalmics and acquired by Accutome in December of |
- (However, the AccuSonic A-Scan does not function
as a B-Scan.); Teknar Ophthasonic A-Scan (K860757);
Teknar Opthasonic A/P III (K903666); DGH 3000A A-
Scan (K872726); DGH 4000 A-Scan/Pach (K913067) |
| Description of the
Device: | The AccuSonic A-Scan device is designed as a biometer,
which uses pulsed echo ultrasound to measure the axial
length, and the location of other structures of the eye. It
utilizes an eye-contact probe to generate and receive the
ultrasound pulses, and provides a one-dimensional display
of returning pulse echoes, with positive peaks to indicate
the location of ocular structures. The distance between
peaks can be measured. |
| Indications for Use: | The instrument is used for measuring the axial length,
anterior chamber depth and lens thickness of the eye. It is
also used for calculating the optical power of the IOL to be
implanted during cataract surgery. |
1
Image /page/1/Picture/1 description: The image shows the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public" on the top line, "Health" on the second line, and "Service" on the third line. The text appears to be extracted from a document or sign.
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized human profiles.
OCT 1 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jeffrey L. Wright Manager, Engineering, Manufacturing & QC Accutome, Inc. 263 Great Valley Parkway MALVERN PA 19355
Re: K032956
Trade Name: AccuSonic A-Scan Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: 90 IYO Dated: August 25, 2003 Received: September 22, 2003
Dear Mr. Wright:
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 transducer intended for use with the AccuSonic A-Scan, as described in your premarket notification:
Transducer Model Number
A-mode 10 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.
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
2
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 (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 C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
AccuSonic A-Scan 510(k) Notification
4.3 Indications for Use
K032956 510(k) Number (if known):_
Device Name: Accusonic A-Scan
Indications for Use:
The instrument is used for measuring the axial length, anterior chamber depth and lens thickness of the eye. It also is used for calculating the optical power of the IOL to be implanted during cataract surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use__/
Over-The Counter Use__________________________________________________________________________________________________________________________________________________________
Nancy C hogdon
(Division Sign-C Division of Reproduct and Radiological Devices 510(k) Number
Page 4 of 19
4
AccuSonic A-Scan 510(k) Notification
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(specify) | Other
(specify) |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | N | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative specify | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ specify | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
N= new indication: P= previously cleared by FDA: E= added under Appendix E
Additional Comments:
CONTINUE ON ANOTHER PAGE IF NEEDED.
evice Evaluation
System includes A-More ID H/A Transducer.
Nancy Hodgson
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Numb