(15 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the B-Scan Plus device based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, resolution). Instead, the 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Advent A/B System K960765).
The device performance is described functionally rather than parametrically.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Ability to image internal structure of the eye using pulsed echo ultrasound. | "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." |
| Functional equivalence to predicate device (Advent A/B System K960765). | The FDA determined the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This implies it meets the same functional and safety performance expectations. |
| Intended Use: Diagnosing pathological or traumatic conditions in the eye. | "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." |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not contain information about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided 510(k) summary does not contain information about experts used to establish ground truth or their qualifications. As there's no mention of a clinical test set in this document, this information would not be present.
4. Adjudication Method for the Test Set
The provided 510(k) summary does not contain information about an adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided 510(k) summary does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This type of study would typically be conducted to evaluate the impact of an AI-assisted device on human reader performance, which doesn't seem to be the focus of this 510(k).
6. Standalone (Algorithm Only) Performance Study
The provided 510(k) summary does not describe a standalone (algorithm only) performance study. The device is a B-Scan ultrasound system, which inherently involves human operation and interpretation of images. The concept of a "standalone algorithm" doesn't directly apply in the same way as it would for, say, an AI-powered image analysis software.
7. Type of Ground Truth Used
Given the lack of a detailed performance study in the document, there's no explicit mention of the type of ground truth used. For a B-scan ultrasound system, ground truth in clinical validation would typically involve:
- Clinical Diagnosis: Based on a combination of patient history, physical examination, and other imaging modalities (e.g., MRI, CT, other specialized ophthalmic tests).
- Surgical Confirmation: If pathology is surgically removed.
- Histopathology: Microscopic examination of tissue samples.
- Expert Consensus: Agreement among multiple, highly qualified clinicians (ophthalmologists) on the diagnosis based on the full clinical picture.
8. Sample Size for the Training Set
The provided 510(k) summary does not mention a training set or its sample size. The B-Scan Plus is a traditional medical imaging device, not an AI/ML-driven device that typically requires a discrete training set in the same manner.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, the document does not describe how ground truth for a training set was established.
Summary of Study Information Gaps:
It's important to note that the provided document is a 510(k) summary, which often focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical trial data with detailed performance metrics. For devices like the B-Scan Plus, the primary means of demonstrating safety and effectiveness relied on showing that its technological characteristics and indications for use were similar to a legally marketed predicate device, and that any differences did not raise new questions of safety or effectiveness. Therefore, many of the detailed study parameters typically associated with AI/ML device submissions are not present here.
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K 070943
510(k) SUMMARY B-Scan Plus
APR 1 9 2007
| Applicant: | Accutome Inc. |
|---|---|
| Address: | 263 Great Valley ParkwayMalvern, PA 19355 |
| Contact Person: | Jeffrey L. WrightManager, 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 MarketedPredicate 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 theinternal structure of the eye. It utilizes an eye-contactprobe to generate and receive the ultrasound pulses, andprovides graphic display of returning pulse echoes to imagethese structures. |
| Indications for Use: | The instrument is used for imagine the internal structure ofthe eye including the opaque media and posterior pathologyfor the purpose of diagnosing pathological or traumaticconditions in the eye. |
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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
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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
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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
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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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | 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-skeletalConventional | ||||||||||
| 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
§ 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.