(179 days)
Not Found
Not Found
No
The description explicitly states the devices are "manually operated" and lists only physical components (stainless steel, polyamide). There is no mention of software, algorithms, or any terms related to AI/ML.
No
The device is a surgical instrument used in plastic-aesthetic operations, specifically orbital retractors for blepharoplasty procedures. It does not actively treat or cure a disease or condition but rather aids in a surgical procedure.
No
Explanation: The device is described as manually operated surgical instruments (retractors) used in plastic-aesthetic operations, specifically blepharoplasty procedures. Its function is to aid in surgery, not to diagnose a condition.
No
The device description explicitly states it is a set of manually operated surgical instruments made of surgical grade stainless steel and Polyamide, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these are "manually operated surgical devices intended to for use in plastic-aesthetic operations of the orbital region". This describes a surgical instrument used directly on a patient during a procedure.
- Device Description: The description confirms they are "manually operated orbital retractors" made of surgical grade materials. This aligns with a surgical instrument, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), performing tests, or providing diagnostic information based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
86 HNI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
orbital region
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.
Not Found
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
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 Drive
Culver City, CA 90230
(310) 410-2769; FAX (310) 410-5519 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Date: | September 16, 1999 |
| Contact: | Kevin Kennan
Senior 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
1
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 .
2
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
3
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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)