(15 days)
Not Found
No
The summary describes a standard ultrasound B-Scan device and does not mention any AI or ML components or capabilities.
No
The device is described as an imaging tool for diagnosis, not for treating conditions.
Yes
The intended use explicitly states the instrument is "for the purpose of diagnosing pathological or traumatic conditions in the eye."
No
The device description explicitly states it utilizes an "eye-contact probe" to generate and receive ultrasound pulses, indicating a hardware component beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The description clearly states that the device is an ultrasound B-Scan used for imaging the internal structure of the eye. It uses an eye-contact probe to generate and receive ultrasound pulses directly on the eye.
- No Sample Analysis: There is no mention of the device analyzing any biological samples taken from the patient.
Therefore, the B-Scan Plus device is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The instrument is used for imaging the internal structure of the eye including the opaque media and posterior pathology for the purpose of diagnosing pathological or traumatic conditions in the eye.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX
Device Description
The B-Scan Plus device is designed as an ultrasound B-Scan which uses pulsed echo ultrasound to image the internal structure of the eye. It utilizes an eye-contact probe to generate and receive the ultrasound pulses, and provides graphic display of returning pulse echoes to image these structures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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.
Advent A/B System (K960765)
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
K 070943
510(k) SUMMARY B-Scan Plus
APR 1 9 2007
| 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: | July 18, 2006 |
| Device Name: | B-Scan Plus |
| Common Name: | Ultrasound B-Scan |
| Classification: | System, Imaging, Pulsed Echo, Ultrasonic |
| (see: 21 CFR 892.1560) Product Code: IYO Panel: 90 | |
| Legally Marketed | |
| Predicate Devices: | Advent A/B System (K960765) |
| Description of the Device: | The B-Scan Plus device is designed as an ultrasound B- |
| Scan which uses pulsed echo ultrasound to image the | |
| internal structure of the eye. It utilizes an eye-contact | |
| probe to generate and receive the ultrasound pulses, and | |
| provides graphic display of returning pulse echoes to image | |
| these structures. | |
| Indications for Use: | The instrument is used for imagine the internal structure of |
| the eye including the opaque media and posterior pathology | |
| for the purpose of diagnosing pathological or traumatic | |
| conditions in the eye. |
1
Image /page/1/Picture/0 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem in the center, which consists of a stylized caduceus-like symbol with three wavy lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Accutome, Inc. % Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44087
APR 1 9 2007
Re: K070943
Trade/Device Name: B-Scan Plus 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: March 30, 2007 Received: April 4, 2007
Dear Mr. Devine:
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 (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. 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.
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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/1/Picture/10 description: The image shows a circular logo with the letters "FDA" in a bold, stylized font. Above the letters, the years "1906-2006" are printed, indicating a centennial celebration. Below the letters, the word "Centennial" is written in a cursive font, and three stars are aligned beneath it.
Protecting and Promoting Public Health
2
Page 2 -
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 Section 510(k) 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 the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
B-Scan Plus 510(k) Notification
4.3 Indications for Use
510(k) Number (if known):_K070 943
Device Name: B-Scan Plus
Indications for Use:
The instrument is used for imaging the internal structure of the eye including the opaque media and posterior pathology for the purpose of diagnosing pathological or traumatic conditions in the eye.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The Counter Use_
Daniel A. Seymon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Page 4 of 22
4
B-Scan Plus 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:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
(PLEASE DO NOT WRITE BELOW THIS LINE . GON TINUE ON ANOTHER PAGE IF NEEDED) Coneurgence of CDGH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K070943
Page 5 of 22