(179 days)
These instruments are manually operated surgical devices intended to for use in plastic-aesthetic operations of the orbital region, including bleparoplasty procedures.
The Karl Storz De la Plaza Blepharoplasty Set are manually operated orbital retractors. The body contact portions of the KSEA De la Plaza Blepharoplasty Set are composed of surgical grade stainless steel and Polyamide.
The provided text is a 510(k) summary for the Karl Storz De la Plaza Blepharoplasty Set, which is a set of manually operated orbital retractors. This type of device falls under a classification that typically relies on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study or extensive device performance testing with a large sample size.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
Here's why and what can be extracted from the provided text:
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Focus on Substantial Equivalence: The primary objective of this 510(k) submission is to demonstrate that the Karl Storz De la Plaza Blepharoplasty Set is "substantially equivalent" to already legally marketed predicate devices (orbital retractors by Padgett Instruments Inc. and Snowden Pencer). This means the FDA determines if the new device has the same intended use and technological characteristics, or if differences don't raise new questions of safety and effectiveness.
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Lack of Performance Study Details: Because the approval pathway is substantial equivalence, there is no mention of a formal study with acceptance criteria, sample sizes, ground truth, or expert evaluations as would be expected for novel devices or those with more complex performance claims (e.g., AI-powered diagnostic tools).
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Device Type: This is a manual surgical instrument (retractors). Its performance is inherently linked to its physical properties (materials, dimensions, design) and fitness for purpose, not algorithmic accuracy.
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Date: The submission date is 1999. Regulatory requirements and the types of studies expected for medical devices, particularly those involving AI or complex software, have evolved significantly since then.
Information that can be extracted or inferred from the document:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Substantial Equivalence to Predicate Devices | The device is substantially equivalent to the predicate devices. |
| Same/Similar Intended Use | Intended use matches or is similar to predicates: plastic-aesthetic operations of the orbital region, including blepharoplasty procedures. |
| Same/Similar Technological Characteristics (Materials, Dimensions) | Materials (surgical grade stainless steel and Polyamide) and dimensions are the same or similar. Minor material difference (unidentified insulation material in predicate vs. Polyamide) found not to raise new issues of safety and effectiveness. |
| No New Issues of Safety and Effectiveness | Device deemed to raise no new issues of safety and effectiveness. |
| Manual Operation | It is a manually operated device. |
2. Sample sized used for the test set and the data provenance: Not applicable. No test set or data provenance is mentioned as this is a physical device seeking substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment by experts for a test set is not part of this substantial equivalence demonstration for a manual surgical instrument.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a manual surgical instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this submission is effectively the established safety and effectiveness of the legally marketed predicate devices.
8. The sample size for the training set: Not applicable. There is no training set mentioned.
9. How the ground truth for the training set was established: Not applicable.
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NOV - 2 1999 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.600 Corporate Pointe DriveCulver City, CA 90230(310) 410-2769; FAX (310) 410-5519 |
|---|---|
| Date: | September 16, 1999 |
| Contact: | Kevin KennanSenior Regulatory Affairs Specialist |
| Device Identification: | Common Name:Retractors |
| Trade Name: (optional)Karl Storz De la Plaza Blepharoplasty Set | |
| Classification:21 CFR 886.4350: manual opthalmic surgical instrument |
Predicates: The KSEA De la Plaza Blepharoplasty Set is substantially equivalent to orbital retractors currently marketed by Padgett Instruments Inc. and Snowden Pencer.
Indication: The KSEA De la Plaza Blepharoplasty Set is intended for use in plastic-aesthetic operations of the orbital region, including bleparoplasty procedures.
The Karl Storz De la Plaza Blepharoplasty Set are manually operated Device Description: orbital retractors. The body contact portions of the KSEA De la Plaza Blepharoplasty Set are composed of surgical grade stainless steel and Polyamide.
The Karl Storz De la Plaza Blepharoplasty Set is substantially Substantial Equivalence: equivalent to the predicate devices since the dimensions, materials and intended uses are the same or similar. The minor difference in materials between the Karl Storz De la Plaza Blepharoplasty Set, surgical grade stainless steel and Polyamide, and the predicate devices, stainless steel and unidentified insulation material, raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.
Signed:
Kevin Kennan Senior Regulatory Affairs Specialist
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding it. The text is written in a sans-serif font and is arranged in a circular pattern.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NUV - 7 1999
Mr. Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy- America, Inc. 600 Corporate Pointe Drive Culver City, CA 90230
Re: K991592 Trade Name: Karl Storz De la Plaza Blepharoplasty Set Regulatory Class: I Product Code: 86 HNI Dated: September 17, 1999 Received: September 23, 1999
Dear Mr. Kennan:
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 .
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Page 2 - Mr. Kevin Kennan
· 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,
・
ARoepl Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is white and is set against a black background. The word "STORZ" is in large, bold letters, with the "O" replaced by a circle. Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller font.
510(k) Number (if known): Not Yet Assigned
Device Name: KSEA De la Plaza Blepharoplasty Set
Indications for Use: These instruments are manually operated surgical devices intended to for use in plastic-aesthetic operations of the orbital region, including bleparoplasty procedures.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
. L. B. hicholas
Division of Ophthalmic I 510(k) Number
V Prescription Use: OR Over-The-Counter Use: (Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 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.