(158 days)
The intended use of the DGH 6000 is the measurement of AL, ACD, LT of the human eye. The DGH 6000 is also intended to calculate the optical power of an IOL that is to be implanted during cataract surgery. The DGH 6000 is intended to be used solely by qualified medical professionals. Clinical consideration and judgment should be applied when using the DGH 6000.
The DGH 6000 A-Scan is a USB plug-in device that uses A-Mode, pulsed echo ultrasound technology to measure the axial length (AL), anterior chamber depth (ACD), and lens thickness (LT) of the human eye. The device includes formulas to calculate the implanted IOL power, using the axial length measurement.
Here's a breakdown of the acceptance criteria and study information for the DGH 6000 Scanmate A, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for performance metrics like accuracy, precision, or agreement with a gold standard. Instead, it relies on the principle of substantial equivalence to a predicate device.
The "acceptance criteria" are implied to be that the DGH 6000 Scanmate A performs equivalently to its predicate device, the DGH 3000A, in terms of safety and efficacy for measuring axial length (AL), anterior chamber depth (ACD), and lens thickness (LT) of the human eye.
Therefore, the table will reflect this implicit criterion rather than precise numerical targets.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence in safety and efficacy to the predicate device (DGH 3000A) for measuring AL, ACD, and LT of the human eye. | The performance tests (non-clinical comparative phantom tests) demonstrated substantial equivalence in safety and efficacy to the legally marketed predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Comparative test block (phantom) tests" as a non-clinical test.
- Sample Size for Test Set: The specific sample size for the test block (phantom) tests is not provided in the document.
- Data Provenance: The tests were non-clinical phantom tests, not human subject data. Therefore, there is no country of origin or retrospective/prospective nature to describe in terms of human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: This information is not provided as the primary performance evaluation was based on non-clinical phantom tests.
- Qualifications of Experts: Not applicable given the above.
4. Adjudication Method for the Test Set
- Adjudication Method: This information is not provided and is likely not applicable given the non-clinical nature of the comparative phantom tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The study described is a non-clinical comparison to a predicate device using phantom data.
- Effect Size: Not applicable as no MRMC study was performed and the device is not described as an AI-assisted diagnostic tool. Its function is to directly measure parameters using ultrasound.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: The core comparative performance was done using non-clinical phantom tests. This could be considered a form of standalone performance as it evaluates the device's measurements against known phantom values. However, the document doesn't detail this as a separate "standalone" study in the typical AI context. The device itself (ultrasound biometer) inherently provides standalone measurements. The software assists in IOL calculations, which is an output of these measurements.
7. The Type of Ground Truth Used
- Ground Truth: For the non-clinical tests, the ground truth was based on the known physical properties and measurements of the comparative test block (phantom).
8. The Sample Size for the Training Set
- Sample Size for Training Set: This information is not applicable/not provided. The DGH 6000 Scanmate A uses established ultrasonic pulse-echo technology and digital signal processing algorithms. It is not described as an AI/machine learning device that requires a distinct "training set" in the conventional sense. The algorithms are built upon scientific principles, not learned from a training dataset.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: This information is not applicable as there is no mention of a training set for an AI/machine learning algorithm. The device's operation is based on physical principles of ultrasound.
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TECHNOLOGY, INC.
510(k) Summary (21 CFR 807.92(c)) 510(k) K093371
Submitter:
Contact Person:
DGH Technology, Inc. 110 Summit Drive, Suite B Exton, PA 19341
M. Luther Detweiler Vice President Regulatory Affairs and Quality Assurance
Telephone: 610-594-9100 Fax: 610-594-0390 Email: Lou@dghkoi.com
Date Summary Prepared:
March 12th, 2010
Device Trade Name:
DGH 6000 Scanmate A.
Device Common Name:
Ultrasound A-Scan biometer.
Device Classification:
Device: System, Imaging, Pulsed Echo, Ultrasonic Panel: Radiology Product Code: IYO Device Class: II Regulation Number: 21 CFR 892.1560
Device: Diagnostic Ultrasonic Transducer Panel: Radiology Product Code: ITX Device Class: II Regulation Number: 21 CFR 892.1570
110 Summit Drive, Suite B Exton, PA 19341
PA 19341
Phone: (610) 594-9100 (800) 722-3883
Fax: (610) 594-0390
APR - 5 2010
.
.
.
.
.
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Image /page/1/Picture/0 description: The image shows the logo for DGH Technology, Inc. The letters "DGH" are in large, bold, black font on the left side of the image. To the right of the letters is a stylized graphic that appears to be a horizontal line with curved extensions above and below it. Above the graphic, the words "TECHNOLOGY, INC." are printed in a smaller font.
Legally Marketed Predicate Device(s):
Description of Device:
The DGH 6000 A-Scan is a USB plug-in device that uses A-Mode, pulsed echo ultrasound technology to measure the axial length (AL), anterior chamber depth (ACD), and lens thickness (LT) of the human eye. The device includes formulas to calculate the implanted IOL power, using the axial length measurement.
Quantel Medical AXIS II Ultrasonic Biometer (K000554)
DGH 3000A Ultrasonic A-Scan (K872726)
Intended Use of the Device:
The intended use of the DGH 6000 is the measurement of AL, ACD, LT of the human eye. The DGH 6000 is also intended to calculate the optical power of an IOL that is to be implanted during cataract surgery. The DGH 6000 is intended to be used solely by qualified medical professionals. Clinical consideration and judgment should be applied when using the DGH 6000.
Technological Characteristics:
Axial length (AL), anterior chamber depth (ACD), and lens thickness (LT) measurements are obtained using the same technology as the predicate device, DGH 3000A. The technology is based on ultrasonic pulse echo technology, whereby short bursts of ultrasonic energy are transmitted and the resulting echoes are captured, amplified, filtered and processed. Specific time distances in the captured echo peaks are then measured and converted into distance information. Digital signal processing algorithms validate individual peaks and proper probe alignment. The resulting measurements and waveforms are then displayed on a PC monitor for the medical (ophthalmic) professional user. In addition, the software assists the user in calculating replacement intraocular lens values based on established IOL calculation formulas.
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Image /page/2/Picture/0 description: The image shows the logo for DGH Technology, Inc. The letters "DGH" are in a bold, sans-serif font. To the right of the letters is a stylized graphic that resembles a wing or a stylized line. Above the graphic, the words "TECHNOLOGY, INC." are printed in a smaller font.
Performance Tests:
The following tests were performed to demonstrate substantial equivalence:
(A) Non-Clinical Tests
- . Comparative test block (phantom) tests
- . EN 60601-1:1990 Medical Electrical Equipment Part 1 General Requirements for Electrical Safety
- . EN 60601-1-2:2002 Medical Electrical Equipment Collateral Standard: Electromagnetic Compatibility
- . NEMA Standard Publication UD-2 2004: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- . NEMA Standard Publication UD-3 2004: Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment.
(B) Clinical Tests
Since the DGH 6000 Scanmate-A uses the same technology as existing devices, clinical tests are not required.
Conclusions:
We have reviewed the results of the performance tests and have determined that the DGH 6000 is substantially equivalent, in safety and efficacy, to the legally marketed predicate device.
Phone: (610) 594-9100 (800) 722-3883
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR - 5 2010
DGH Technology, Inc. % Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062
Re: K093371
Trade/Device Name: DGH 6000 Scanmate A Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed Doppler imaging system Regulatory Class: II Product Code: IYO and ITX Dated: March 23, 2010 Received: March 24, 2010
Dear Mr. Devine:
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 DGH 6000 Scanmate A, as described in your premarket notification:
Transducer Model Number
DGH 6000
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 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.
Sincerely yours,
Donald J. St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
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Indications for Use
510(k) Number (if known): K093371
Device Name: DGH 6000 Scanmate A
Indications for Use: The intended use of the DGH 6000 is the measurement of AL. ACD, LT of the human eye. The DGH 6000 is also intended to calculate the optical power of an IOL that is to be implanted during cataract surgery. The DGH 6000 is intended to be used solely by qualified medical professionals. Clinical consideration and judgment should be applied when using the DGH 6000.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
KMR
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Page 1 of 3
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. Attachment 3
Indications for Use Form
.. ...........................................................................................................................................................................
13
510(k) K093371 System: DGH 6000 Scanmate A Transducer: DGH 6006
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | A-Mode |
| Ophthalmic | Ophthalmic | P | ||||||
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K093371
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Indications for Use Form
510(k) K093371 Transducer: DGH 6006
Intended Use: The intended use of the DGH 6006 transducer is the measurement of AL, ACD, LT of the human eye. The DGH 6006 transducer is intended to be used solely by qualified medical professionals. Clinical consideration and judgment should be applied when using the DGH 6006 transducer.
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | A-Mode | |
| Ophthalmic | Ophthalmic | P | |||||||
| Fetal Imaging& Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Specify) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
(Division Sign-Off)
Division of Radiological Office of In Vitro Diagnostic Device Ev
510K K093371
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§ 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.