(66 days)
Katena Ophthalmic Speculum, Storz Ophthalmic Speculum, Rhein Ophthalmic Speculum, Stephens Ophthalmic Speculum
Not Found
No
The device description and performance studies focus on the mechanical properties and function of a physical speculum, with no mention of AI or ML.
No
The device is described as a speculum for eyelid retraction, which is a surgical tool, not a therapeutic device that treats a condition or disease. Its function is to facilitate a procedure, not to provide therapy itself.
No.
Explanation: The device is described as a speculum used for retraction of eyelids during ophthalmic procedures, and performance studies mention retraction tension tests. There is no indication that the device is used to diagnose a condition or disease.
No
The device description clearly states it is a "single use ophthalmic device designed to retract the eyelids," which is a physical hardware device. The performance studies also describe testing of physical attributes like blade measurements and retraction tension.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for the "retraction of eyelids in various ophthalmic procedures." This describes a physical manipulation of a body part during a medical procedure.
- Device Description: The description reinforces this by stating it's a "single use ophthalmic device designed to retract the eyelids."
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with bodily specimens or diagnostic purposes.
- Focus on Physical Performance: The performance studies described (Dimensional Equivalency Test, Retraction Tension Tests) focus on the physical characteristics and functionality of the device in terms of retracting eyelids, not on analyzing biological samples.
Therefore, this device is a surgical instrument used for a physical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Speculum made for single use in the retraction of eyelids in various ophthalmic procedures.
Product codes
86HNC
Device Description
A single use ophthalmic device designed to retract the eyelids.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyelids
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)
- Dimensional Equivalency Test The blade measurements of the speculum were substantially 1.0 equivalent to the measurements of the predicate devices listed above.
- 2.0 Retraction Tension Tests-The mechanism and holding ability of the Stephens speculum was found to perform as well as the predicate devices.
Clinical Tests: None Adverse S & E Information: None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Katena Ophthalmic Speculum, Storz Ophthalmic Speculum, Rhein Ophthalmic Speculum, Stephens Ophthalmic Speculum
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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1 2002 NOV
Page 5
510 (k) Summary
Device Trade or Proprietary Name: Stephens Disposable Speculum
Device Common or Usual Name or Classification: Ophthalmic Speculum
Classification Name/Product Code(s): 86HNC, Ophthalmic Speculum
Predicate Devices: Katena Ophthalmic Speculum, Storz Ophthalmic Speculum, Rhein Ophthalmic Speculum, Stephens Ophthalmic Speculum
Device Description: A single use ophthalmic device designed to retract the eyelids.
Device Use: Designed for single use retracting of eyelids in various ophthalmic procedures.
Classification: Class I
Comparison to Predicate Devices:
| Device Name | Katena
Ophthalmic
Speculum | Storz Ophthalmic
Speculum | Rhein Ophthalmic
Speculum | Stephens
Ophthalmic
Speculum |
|--------------|-----------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|
| Intended Use | Retraction of
eyelids in various
ophthalmic
procedures | Retraction of
eyelids in various
ophthalmic
procedures | Retraction of
eyelids in various
ophthalmic
procedures | Retraction of
eyelids in various
ophthalmic
procedures |
| Performance | Compatible | Compatible | Compatible | Same |
| Material | 420 Stainless Steel | 420 Stainless Steel | 420 Stainless Steel | 420 Stainless Steel
& Polystyren |
Performance Tests and Conclusions:
- Dimensional Equivalency Test The blade measurements of the speculum were substantially 1.0 equivalent to the measurements of the predicate devices listed above.
- 2.0 Retraction Tension Tests-The mechanism and holding ability of the Stephens speculum was found to perform as well as the predicate devices.
Clinical Tests: None Adverse S & E Information: None
H. Johnson
Archana Johnson
10-4-02
Date
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 2002 NOV
Stephens Instruments c/o Ms. Archana Johnson 2500 Sandersville Road Lexington, KY 40511
K022836 Re:
Trade Name: Stephens Disposable Speculum Classification Regulation Number: 886.4350 Regulatory Class: I Product Code: HNC Dated: August 21, 2002 Received: August 27, 2002
Dear Ms. Johnson:
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 (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 (OS) 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
Page 2 – Ms. Archana Johnson
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 and additionally 21 CFR Part 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" (21CFR 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) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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Pg 13 of 13
:
510(k) Number : K022836
Device Name : Ophthalmic Speculum
Indications For Use :
Speculum made for single use in the retraction of eyelids in various ophthalmic procedures.
Debra Falls
Unision Slan-Division of Ophthalmic I and Throat Dev
510(k) Number K022836
Prescription Use
(Per 21 CFR 801.109)