(66 days)
Speculum made for single use in the retraction of eyelids in various ophthalmic procedures.
A single use ophthalmic device designed to retract the eyelids.
This document describes the acceptance criteria and the study conducted for the Stephens Disposable Speculum (K022836).
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | Retraction of eyelids in various ophthalmic procedures (must be equivalent to predicate devices). | Performance Test: Comparison to Predicate Devices. Conclusion: Intended Use is "Retraction of eyelids in various ophthalmic procedures," which is the same as the predicate devices (Katena Ophthalmic Speculum, Storz Ophthalmic Speculum, Rhein Ophthalmic Speculum, Stephens Ophthalmic Speculum). This indicates the device meets the intended use criteria. |
| Performance | Device must perform comparably to predicate devices in terms of retraction tension and holding ability. | Performance Test: Retraction Tension Tests. Conclusion: "The mechanism and holding ability of the Stephens speculum was found to perform as well as the predicate devices." This indicates the device meets the performance criteria. |
| Dimensional Equivalency | Blade measurements of the speculum must be substantially equivalent to predicate devices. | Performance Test: Dimensional Equivalency Test. Conclusion: "The blade measurements of the speculum were substantially equivalent to the measurements of the predicate devices listed above." This indicates the device meets the dimensional equivalency criteria. |
| Material | Compatibility with existing materials used in predicate devices for ophthalmic speculums. | Performance Test: Material composition comparison. Conclusion: The device uses 420 Stainless Steel & Polystyrene, while the predicate devices use 420 Stainless Steel. The document implies that this combination is compatible and does not negatively impact performance, aligning with substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not indicate any clinical trials or tests involving human subjects or patient data for the Stephens Disposable Speculum. Therefore, there is no "test set" in the context of clinical data for this device. The evaluations were based on engineering performance tests and comparison to predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable, as no clinical test set requiring expert ground truth establishment was conducted. The evaluation was primarily based on objective engineering measurements and comparison to existing devices.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring adjudication was conducted.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not conducted. This device is a Class I ophthalmic speculum, and the submitted information focuses on substantial equivalence based on physical and mechanical performance compared to predicate devices, not on a clinical effectiveness study involving human readers or AI.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone (algorithm only) performance study was not conducted. The Stephens Disposable Speculum is a physical medical device, not an algorithm or AI system.
7. Type of Ground Truth Used:
For the performance tests conducted (Dimensional Equivalency and Retraction Tension Tests), the "ground truth" was established by objective engineering measurements and comparisons to the specifications and performance characteristics of the legally marketed predicate devices. There was no pathology, outcomes data, or expert consensus on clinical data used as ground truth.
8. Sample Size for the Training Set:
Not applicable. This device is a physical medical device, and the submission did not involve machine learning or AI, and therefore no "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there was no training set.
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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 | KatenaOphthalmicSpeculum | Storz OphthalmicSpeculum | Rhein OphthalmicSpeculum | StephensOphthalmicSpeculum |
|---|---|---|---|---|
| Intended Use | Retraction ofeyelids in variousophthalmicprocedures | Retraction ofeyelids in variousophthalmicprocedures | Retraction ofeyelids in variousophthalmicprocedures | Retraction ofeyelids in variousophthalmicprocedures |
| 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
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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.
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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)
§ 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.