(103 days)
Not Found
No
The device description details a mechanical system for eye immobilization using suction and a speculum, with no mention of AI/ML terms or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML devices.
No
The device is intended to immobilize the eye during procedures, not to treat a disease or condition.
No
The device description and intended use clearly state that the Oculostat is used to immobilize the eye during procedures, effectively functioning as a surgical accessory rather than a diagnostic tool that identifies or assesses a medical condition.
No
The device description clearly states it consists of a scleral vacuum suction ring attached to a medical quality plastic ophthalmic speculum, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reduce eye movement and stabilize the eye in any procedure in which the globe needs to be immobilized." This describes a surgical or procedural aid used directly on the patient's body.
- Device Description: The description details a physical device (scleral vacuum suction ring attached to a speculum) that interacts with the eye to achieve stabilization.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, tissue, etc.) in vitro (outside the body).
- Providing diagnostic information based on the analysis of samples.
- Reagents, calibrators, or controls typically associated with IVD tests.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Oculostat does not fit this description. It is a surgical instrument used to facilitate a procedure.
N/A
Intended Use / Indications for Use
The Oculostat, by Laser Center Development Corporation, is intended to reduce eye movement and stabilize the eye in any procedure in which the globe needs to be immobilized. The device is provided sterile and it is disposable for single use only.
Product codes (comma separated list FDA assigned to the subject device)
86 HNC
Device Description
The Oculostat by Laser Center Development Corporation consists of a scleral vacuum suction ring attached to a medical quality plastic ophihalmic speculum. After retracting the eyelids and inserting the lid margins into the speculum portion of the Oculostat, the suction-vacuum ring is attached to the sclera by sequentially contering, depressing, and enguing low vacuum (30mm Hg or less) by pump or spring-loaded syringe. The frictional forces between the eyelids and speculum, together with the vacuum ring, hold the eye steady despite extraocular muscle activity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye / globe
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.
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
§ 886.4350 Manual ophthalmic surgical instrument.
(a)
Identification. A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.
0
JUL 1 5 1898
K981235 Oculostat
0 . J . J . J . J . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
P.16
510(k) Summary
SUBMITTED:
Submitted on behalf of:
TEL :
Company Name: Address:
Phone: Fax:
Laser Center Develonment Corporation 709 The Hamptons Lane Town & Country, MO 63017 314-514-1478 314-434-7030
CONTACT PERSON:
Francis E. O'Donnell, Jr., M.D.
OFFICIAL CORRESPONDENT:
Firm Name: Address:
Phone: Fax:
Francis E. O'Donnell, Jr., M.D. Laser Center Development Corporation 709 The Hamptons Lanc Town & Country, MO 63017 314-514-1478 314-434-7030
DATE SUMMARY PREPARED:
TRADE NAME:
COMMON NAME:
Ophthalmic speculum
May 27, 1998
Oculostat
SUBSTANTIALLY EQUIVALENT TO: The Oculostat™ by Laser Center Development Corporation is substantially equivalent to the Eye Fixation Speculum, by eyeFix, Inc., which was determined by FDA to be marketable per K964289.
DESCRIPTION OF THE DEVICE: The Oculostat by Laser Center Development Corporation consists of a scleral vacuum suction ring attached to a medical quality plastic ophihalmic speculum. After retracting the eyelids and inserting the lid margins into the speculum portion of the Oculostat, the suction-vacuum ring is attached to the sclera by sequentially contering, depressing, and enguing low vacuum (30mm Hg or less) by pump or spring-loaded syringe. The frictional forces between the eyelids and speculum, together with the vacuum ring, hold the eye steady despite extraocular muscle activity.
INDICATIONS FOR USE: The Oculostat, by Laser Center Development Corporation, is intended to reduce eye movement and stabilize the eye in any procedure in which the globe needs to be immobilized. The device is provided sterile and it is disposable for single use only.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 5 1998
Francis E. O'Donnell, Jr., M.D. President Laser Center Development Corp. 1028 S. Kirkwood Road, Suite A Kirkwood, MO 63122-7222
Re: K981235 Trade Name: Oculostat Speculum Regulatory Class: I Product Code: 86 HNC Dated: May 27, 1998 Received: May 29, 1998
Dear Dr. O'Donnell :
We have reviewed your Section 510(k) 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 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.
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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
2
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Roerl. Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
ﮩ
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K981235
Oculostat Device Name: __
Indications For Use:
Oculostat is intended to reduce eye movement and stabilize the eye in any procedure in which the globe needs to be immobilized.
(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) OR Over-The-Counter Use
(Optional Format 1-2-96)
Amwilliams
(Division Sign-Off)
Division of Ophthalmic Device
510(k) Number K981235