(15 days)
Not Found
No
The document describes a standard ultrasound imaging system and does not mention any AI or ML components in the device description, intended use, or any other section.
No.
The intended use explicitly states "Diagnostic ultrasound imaging or fluid flow analysis," and the device description outlines its function for "noninvasive imaging of the anterior segment of the eye." There is no mention of treating or alleviating any condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic" and details its usefulness "in evaluation of pathologies" for management.
No
The device description explicitly states that the system consists of a handpiece containing a transducer, interfacing electronics, and a personal computer with software. This indicates the device includes significant hardware components 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 provide information for diagnosis, monitoring, or screening.
- Device Function: The Ophthalmic Imaging System (OIS) is an ultrasound imaging system. It uses sound waves to create images of the internal structures of the eye. This is a form of in vivo diagnostic imaging, meaning it is performed directly on the living body.
- Intended Use: The intended use describes the device as providing "real-time, high-resolution images of the intraocular anatomy" and being "useful in evaluation of pathologies." This is consistent with diagnostic imaging, not in vitro testing of samples.
- Device Description: The description details a handpiece with a transducer, interfacing electronics, and software to generate images. This is the typical setup for an ultrasound system.
- Lack of Sample Handling: There is no mention of collecting or analyzing biological samples from the patient.
In summary, the OIS is a medical device used for diagnostic imaging within the body, not for testing samples outside the body. Therefore, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The OIS provides real-time, high-resolution images of the intraocular anatomy and is, therefore, useful in evaluation of pathologies of the anterior segment such as trauma, tumors, cysts, and glaucoma. It can also be used during ophthalmic surgery to monitor the changes in anatomical structures such as the anterior angle, Schlemm's canal and related outflow structures of the eye, for glaucoma management.
Product codes
IYO, ITX
Device Description
The Ophthalmic Imaging System (OIS) is an ultrasound system designed for noninvasive imaging of the anterior segment of the eye through the use of standard ultrasound imaging pulse-echo techniques.
The system consists of a handpiece containing a high-frequency transducer, connected to interfacing electronics in the Transducer Interface Module (TIM) which is in turn connected to a personal computer with video display. Software developed by iScience Surgical runs on the computer controlling the system and generating the image.
The OIS is used with a sterile disposable tissue interface (Imaging Gel Cap) which is attached to the handpiece for direct contact with the eye during imaging. The OIS may also be used with a sterile Sheath Adapter Assembly for sterile field applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
anterior segment of the 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K05/304
3 2005 JUN
510(K) Summary
| Submitter's Name: | iScience Surgical Corporation | |
|---|---|---|
| Submitter's Address: | 3696A Haven Avenue | |
| Redwood City, CA 94063 | ||
| Submitter's Telephone: | Phone (650) 421-2700 | |
| Fax (650) 421-2701 | ||
| Contact Name: | Ron Yamamoto | |
| Date Summary was Prepared: | April 20, 2005 | |
| Trade or Proprietary Name: | iScience Surgical Ophthalmic Imaging System (OIS) | |
| Common or Usual Name: | Ultrasound Echo Imaging System | |
| Classification Name: | System, Imaging, Pulse Echo Ultrasound | |
| Predicate Devices: | Device Name | 510(k) Number |
| UBM Plus, Model P45 | K003141 | |
| Artemis Ultrasonic Arc-Scan System | K021333 |
Description of the Device and Summary of the Technological Characteristics:
The Ophthalmic Imaging System (OIS) is an ultrasound system designed for noninvasive imaging of the anterior segment of the eye through the use of standard ultrasound imaging pulse-echo techniques.
The system consists of a handpiece containing a high-frequency transducer, connected to interfacing electronics in the Transducer Interface Module (TIM) which is in turn connected to a personal computer with video display. Software developed by iScience Surgical runs on the computer controlling the system and generating the image.
The OIS is used with a sterile disposable tissue interface (Imaging Gel Cap) which is attached to the handpiece for direct contact with the eye during imaging. The OIS may also be used with a sterile Sheath Adapter Assembly for sterile field applications.
Substantial Equivalence:
The OIS device is similar to predicate devices such as the UBM Plus, Model P45 from Paradigm Medical Industries and the Artemis VHF Ultrasound Arc-scan System from Ultralink LLC. Like the OIS device, these predicate devices are intended to provide high resolution ultrasound images of the anterior portion of the eye. All systems use a very high frequency, mechanically scanned transducer and use patient contact materials that are biocompatible and have a history of use in medical devices. The images are all displayed on video and/or PC monitors. All systems have similar medical electronic controllers and utilize standard computer hard drives to store images.
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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 2005 JUN
iScience Surgical Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K051304
Trade Name: iScience Surgical Ophthalmic Imaging 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: IYO and ITX Dated: May 16, 2005 Received: May 19, 2005
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the indication in We have reviewed your Section 310(K) prothanter no is substantially equivalent (for the indications) referenced above and we nave decemined and as a concess marketed in interstate for use stated in the encrosury manative production produced Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food Frank commerce prior to May 20, 1770, the enabilities with the provisions of the Federal Food, Drug, and devices that have been reclassified in accreadios the device, subject to the general controls Cosmetic Act (Act). Tou may, morelors, haravisions of the Act include requirements for annual provisions of the Act. "The general controlation practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intentificatiffication I his determination of substantal equivaled appress to as described in your premarket notification:
Transducer Model Number
OIS-HP-80A
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classifica (Sec above) into enas con regulations affecting your device can be may be subject to Such additions, Title 21, Parts 800 to 898. In addition, FDA may publish found in the Oous ents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that YDA's Issualled of a saccamatics with other requirements of the Act of any FDA has made a decemination that your are rederal agencies. You must comply with all
2
Page 2 - Mr. Job
the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); the Act's requirements, including, but not innica to: regaritments as set forth in the quality
labeling (21 CFR Part 801); good manufacturing practice requirements as et rodu labeling (21 CFR Part 801); good manufacturing practice requirences on en en entrol
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radia systems (QS) regalation (21 -542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the prior to shipping the fi This determination of substantial equivalence is grante should contain complete first device, you submit a posiclearantes special reportuction line devices, requested in
information, including acoustic output measurements based on production in a product information, including acoustic output neasur information for Manufacturers Seeking
Appendix G, (enclosed) of the Center's September 30, 1997 "Information " is Appendix G, (enclosed) of the Center's Septems and Transducers." If the special report is Marketing Clearance of Diagnosic Offically and Iran granter than approved byels), then
incomplete or contains unacceptable values (e.g., acoustic one new may be considered incomplete or contains unaceeplable values (e:g., accusers cappling of the production of the 510(k)
the 510(k) clearance may not apply to the production units which as a resu adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and the The special report should reference the manufactured 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. I his letter will anow you to begin mancems your device to a legally marketed predicate device The FDA finding of substantial equivalence of your device to began y
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 If you desire specific advice for your device of your and success note the regulation entitied, contact the Office of Compliance at (210) 270 - 120.97). You may obtain other "Misoranaing by relevelice to premarket nother (Act from the Division of Small Manufacturers, general information on your responsionnies ander the risober (800) 638-2041 or (301) 443-6597 or International and Ootisainer Tiow.fda.gov/cdrl/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Dr. Ewa Czerska at (301) 594-1212.
Sincerely yours,
Robe Pally
$\xi$
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
3
4.3 Indications for Use
iScience Surgical Ophthalmic Imaging System System: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | Comb. Modes | Other | |||||
|---|---|---|---|---|---|---|---|---|
| B | M | PW | ||||||
| D | CW | |||||||
| D | Color | |||||||
| Dopp | ||||||||
| General | ||||||||
| (Track I | ||||||||
| Only) | Specific | |||||||
| (Tracks I & III) | ||||||||
| Ophthalmic | Ophthalmic | N | ||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal: | ||||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatricd: | ||||||||
| Small Organ (Thyroid, | ||||||||
| Breast, Testes, etc.): | ||||||||
| Neonatal Cephalic: | ||||||||
| Adult Cephalic: | ||||||||
| Trans-rectal: | ||||||||
| Trans-vagina | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Convent.): | ||||||||
| Musculo-skel. | ||||||||
| (Superfic): | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. | ||||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel: | |||||||
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: The OIS provides real-time, high-resolution images of the intraocular anatomy and is, therefore, useful in evaluation of pathologies of the anterior segment such as trauma, tumors, cysts, and glaucoma. It can also be used during ophthalmic surgery to monitor the changes in anatomical structures such as the anterior angle, Schlemm's canal and related outflow structures of the eye, for glaucoma management.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)