(66 days)
Scissors made for single use in the cutting of tissue in various ophthalmic procedures.
A single use ophthalmic device designed for cutting tissues.
Here's an analysis of the provided documents regarding the acceptance criteria and study for the Stephens Disposable Scissors:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Dimensional Equivalency | "The blade measurements of the scissors were substantially equivalent to the measurements of the predicate devices listed above." |
| Sharpness - Number of Cuts | "It was found that Stephens scissors perform as well as the predicate devices." |
| Sharpness - Initial Cutting Sharpness | "It was found that Stephens scissors perform as well as the predicate devices." |
Explanation of Criteria:
- Dimensional Equivalency: This implies that the critical dimensions (like blade length, width, angle) of the Stephens Disposable Scissors had to be sufficiently close to those of the predicate devices to ensure similar function and safety.
- Sharpness (Number of Cuts & Initial Cutting Sharpness): The device needed to demonstrate comparable cutting ability to the predicate devices, both in terms of how many cuts it could perform effectively and its initial sharpness. This is crucial for an ophthalmic scissor to ensure precise and efficient tissue cutting.
2. Sample Size and Data Provenance for Test Set:
- Sample Size: The document does not specify the exact sample size used for the Dimensional Equivalency Test or the Sharpness Tests. It only states that the tests were "performed."
- Data Provenance: The documents do not provide information on the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of performance bench testing, it would inherently be prospective, but the location is unknown.
3. Number of Experts and Qualifications for Ground Truth:
- Number of Experts: Not applicable. These tests are objective bench tests, not involving expert interpretation.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for Test Set:
- Adjudication Method: Not applicable. These were objective physical performance tests, not requiring human adjudication of results in the traditional sense of clinical imaging or diagnostic studies. The results would be quantitative measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, an MRMC comparative effectiveness study was not performed.
- Effect Size: Not applicable, as no such study was conducted. This device is a surgical instrument and its performance is evaluated by physical characteristics rather than diagnostic accuracy involving human readers.
6. Standalone Performance Study:
- Standalone Performance Study: Yes, standalone performance tests were conducted. The "Dimensional Equivalency Test" and "Sharpness Tests" (both number of cuts and initial cutting sharpness) evaluate the device's inherent physical characteristics and performance independently. There is no human-in-the-loop component for these specific tests.
7. Type of Ground Truth Used:
- Type of Ground Truth: The ground truth for these performance tests was based on objective physical measurements and comparisons to predicate devices. For dimensional equivalency, it would be measured dimensions against predicate device specifications. For sharpness, it would be quantitative sharpness metrics (e.g., force required to cut, number of cuts on a standardized material) compared to the performance of predicate devices.
8. Sample Size for Training Set:
- Sample Size: Not applicable. This is not an AI/ML device that requires a training set. The device is a physical surgical instrument.
9. How Ground Truth for Training Set Was Established:
- Ground Truth Establishment: Not applicable, as there is no training set for this device.
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1 2002 NOV
Page 5
510 (k) Summary
Device Trade or Proprietary Name: Stephens Disposable Scissors
Device Common or Usual Name or Classification: Ophthalmic Scissors
Classification Name/Product Code(s): 86HNF, Ophthalmic Scissors
Predicate Devices: Katena Ophthalmic Scissors, Storz Ophthalmic Scissors, Rhein Ophthalmic Scissors, Stephens Ophthalmic Scissors
Device Description: A single use ophthalmic device designed for cutting tissues.
Device Use: Designed for single use cutting in various ophthalmic procedures.
Classification: Class I
Comparison to Predicate Devices:
| Device Name | KatenaOphthalmicScissors | Storz OphthalmicScissors | Rhein OphthalmicScissors | StephensOphthalmicScissors |
|---|---|---|---|---|
| Intended Use | Cutting of tissue invarious ophthalmicprocedures | Cutting of tissue invarious ophthalmicprocedures | Cutting of tissue invarious ophthalmicprocedures | Cutting of tissue invarious ophthalmicprocedures |
| Performance | Compatible | Compatible | Compatible | Same |
| Material | 420 Stainless Steel | 420 Stainless Steel | 420 Stainless Steel | 420 Stainless Steel& Polystyrene |
Performance Tests and Conclusions:
- Dimensional Equivalency Test -- The blade measurements of the scissors were substantially 1.0 equivalent to the measurements of the predicate devices listed above.
- 2.0 Sharpness Tests-The sharpness tests were performed both by number of cuts and initial cutting sharpness of the scissors. It was found that Stephens scissors perform as well as the predicate devices.
Clinical Tests: None Adverse S & E Information: None
A. Johnson
10.4.02
Date
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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 stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
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
K022840 Re:
Trade Name: Stephens Disposable Scissors Classification Regulation Number: 886.4350 Regulatory Class: I Product Code: HNF 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 (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.
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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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510(k) Number : K022840
Device Name : Ophthalmic Scissors
Indications For Use :
Scissors made for single use in the cutting of tissue in various ophthalmic procedures.
Debnah Faus
(Division Slon-Off) ision of Ophthalmic E Nose and Throat Devis 510(k) Number
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.