(165 days)
NOT APPLICABLE
No
The summary describes a standard ultrasound imaging device for the eye and explicitly states that the technological characteristics are the same as the predicate device, with no mention of AI or ML.
No.
The device is described as measuring dimensions and providing images for evaluation and planning, not for treating conditions.
Yes
The device is described as being used for "evaluation and/or planning of refractive surgery and evaluation of pathologies of the anterior segment such as trauma, tumors, cysts, glaucoma and hypotony," which are all diagnostic activities. It provides images and measurements of human eye components and structures to help identify and assess medical conditions.
No
The device description explicitly mentions "components" and "materials from which the patient-contact portions of the device are made," indicating a hardware component (an ultrasound transducer and system) is involved in acquiring the images and measurements. The device is not solely software.
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.
- Device Function: The description clearly states the device uses ultrasound to image and measure structures within the human eye. It does not analyze samples taken from the body.
- Intended Use: The intended use is for imaging and measuring eye components and pathologies in situ.
Therefore, this device falls under the category of a diagnostic imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
To measure dimensions of components of the human eye. To provide tomographic, high-resolution ultrasound images of the anterior portion of the eye. It is also designed to measure these tissues and structures, such as anterior chamber depth, angle to-angle width and sulcus-to-sulcus width. Measurement also may be made of pathologic structures such as solid masses or cysts and it therefore is useful in evaluation and/or planning of refractive surgery and evaluation of pathologies of the anterior segment such as trauma, tumors, cysts, glaucoma and hypotony.
Product codes
90 IYO, ITX
Device Description
The Artemis™ is an Ultrasonic Pulsed Echo Imaging System. The technological characteristics of this device are the same as those for the predicate device except for the models of some of the components, and the method by which the arc-scanning motion is achieved. The materials from which the patient-contact portions of the device are made are the same as in the predicate device. The acoustic output of this device is similar to that of predicate devices and well below the preamendment levels described in the guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers."
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic Pulsed Echo Imaging
Anatomical Site
Human Eye (anterior portion)
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
The determination of substantial equivalence is granted on the condition that prior to shipping the first device, a postclearance special report is submitted. 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.
§ 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
do 21333 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
I. Submitter: George Wiseman, Ultralink LLC. 2083 Hawaii Ave., N.E. St. Petersburg, FL 33707 Ph: 727-527-1277 FAX 727-527-1945
II. Classification Names and Numbers: Ultrasonic Pulsed Echo Imaging System, 90-1YO, FR number 892.1560
III. Common/Usual Name: Ultrasound Bio Microscope
OCT 0 8 2002
IV. Proprietary Names: Artemis™ VHF Ultrasonic Arc-scan System
V. Establishment Registration Number: in progress
VI. Classification: Class II, Tier II. Described in CFR 892.1560
VII. Substantial Equivalence: The Artemis™ is substantially equivalent to the classified device described in CFR 21 892.1560. "Ultrasonic Pulsed Echo Imaging System," and to other ultrasound systems that have been cleared by the 510(k) process, particularly the Artemis™ VHF Ultrasonic Arc-scan System cleared by Ultralink LLC in K003890.
The 510(k) Substantial Equivalence Decision-making Process (detailed) from ODE Guidance Memorandum #86-3 was followed as described below:
-
These products have the same intended use, to produce high-resolution ultrasound images of the anterior portion of the eye, and to measure these tissues such as the thickness of the cornea and its individual layers, the epithelium stroma and surgically induced surfaces. They can also be used to measure pathologic structures such as solid masses or cysts.
-
The technological characteristics of this device are the same as those for the predicate device except for the models of some of the components, and the method by which the arc-scanning motion is achieved.
-
The materials from which the patient-contact portions of the device are made are the same as in the predicate device.
-
The acoustic output of this device is similar to that of predicate devices and well below the preamendment levels described in the guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers."
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines above them that resemble a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. George D. Wiseman President and CEO ULTRALINK, LLC 2083 Hawaii Ave., N.E. ST. PETERSBURG FL 33707
Re: K021333
Trade Name: Artemis VHF Ultrasonic Arc-Scan System 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: 90 IYO and ITX Dated: August 14, 2002 Received: August 14, 2002
Dear Mr. Wiseman:
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 Artemis VHF Ultrasonic Arc-Scan System, as described in your premarket notification:
Transducer Model Number
H40
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.
2
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) 5944639. 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) 638-041 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,
Vorind A. Regenon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
3
Diagnostic Ultrasound Indications for Use Form
510(k) Number: __
Device Name: Artemis Ultrasonic Pulsed Echo Imaging System
Intended Use: To measure dimensions of components of the human eye.
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ✓ | ✓ | ||||||||
| 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: To provide tomographic, high-resolution ultrasound images of the anterior portion of the eye. It is also designed to measure these tissues and structures, such as anterior chamber depth, angle to-angle width and sulcus-to-sulcus width. Measurement also may be made of pathologic structures such as solid masses or cysts and it therefore is useful in evaluation and/or planning of refractive surgery and evaluation of pathologies of the anterior segment such as trauma, tumors, cysts, glaucoma and hypotony.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive and Radi 510(k) Number
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