Retraction Sheaths are used to form an artificial working access. The introduction of a telescope permits illumination and observation of the operating site. The rotatable stopcock permits continuous irrigation. The retraction sheaths are used in endoscopic plastic surgery in endo-faceliff, eyebrow and forehead lift specialties.

The Obturator (mandrin) is used in conjunction with the sheath for atraumatic insertion into body cavities.

The Optical Retractors are used to maintain a subcutaneous space during surgical procedures for plastic/cosmetic and reconstructive surgery. They can be combined with an endoscope to visualize the tissue and anatomic structures.

The Optical Holders with optical retractors allow single-handled maintenance of subcutaneous pocket while providing traction. One hand is free for dissection. The optical holder or a guide holds the endoscope in position under the blade of the retractor.

Suction/Irrigation Instruments are used to keep the operating site and the endoscope free of blood and secretion: at the same time it serves as a retractor to hold tissue out of the instrument is used in endoscopic surgery of the nose, nasal sinuses, and in endoscopic plastic surgery.

The Micro Grasping Forceps with HF are used to grasp and to coagulate small blood vessels.

The HF Coagulation Suction Aspirator suctions and coagulates while holding tissue out of the way during the endoscopic operation, e.g. of the larynx in connection with CO2 lasers, in mediastinoscopy or in plastic surgery.

The Bipolar Coagulation Suction Tube (bipolar aspiration tube) is used for aspiration and coagulation of small lesions.

The Bipolar Coagulation Instrument is designed for used in plastic/cosmetic and reconstructive surgery to coagulate small blood vessels that bleed from blunt dissection of subcutaneous tissue. Smoke caused by cauterization of tissue is evacuated from the operative site when used in conjunction with the suction applicator.

Bipolar electrodes are used to coagulate and to remove or destroy tissue by the use of bipolar HF current.

Device Description

The EPS instruments consist of endoscopes, irrigation/suction cannulas/ sheaths and holders for the endoscope, retractors, forceps, and electrodes (in addition to the exempt dissectors, elevators; probes, and forceps).

AI/ML Overview

The provided document is a 510(k) summary for "EPS. Instruments for Endoscopic Plastic Surgery." This document focuses on establishing substantial equivalence to existing devices rather than proving a novel device meets specific performance criteria through a study. Therefore, standard acceptance criteria and study designs typically associated with AI/ML or new therapeutic devices are not applicable here.

Here's a breakdown of why and what information is provided:

No Acceptance Criteria or Performance Study:

The core statement in the document (Section 5.0) is "No data generated." and "No clinical tests performed." (Section 6.0). This explicitly states that no performance data or clinical tests were conducted to establish acceptance criteria or demonstrate the device meets them.

The submission relies on demonstrating substantial equivalence to existing, legally marketed devices. This means the manufacturer is asserting that their new device is as safe and effective as a predicate device already approved by the FDA, based on similar technological characteristics and intended use, rather than proving performance against quantitative benchmarks.

Therefore, the following aspects of your request cannot be answered from the provided text as they are not relevant to a 510(k) submission based on substantial equivalence without performance data:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and data provenance
Number of experts used to establish ground truth and their qualifications
Adjudication method
Multi-reader multi-case (MRMC) comparative effectiveness study
Standalone (algorithm only) performance
Type of ground truth used
Sample size for the training set
How ground truth for the training set was established

Information Available from the Document:

While a performance study wasn't conducted, the document does contain information relevant to its submission:

1. A table of acceptance criteria and the reported device performance:

As noted, no performance data was generated or submitted. The criteria for acceptance in a 510(k) substantial equivalence submission (without performance data) revolve around demonstrating that the device has:

Same intended use as the predicate device(s).
Same technological characteristics as the predicate device(s) OR if different, that the differences do not raise new questions of safety and effectiveness.

The document claims: "The devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manuals." (Section 7.0) and "The bipolar instruments are developed to conform to the standards IEC601-2-18." (Section 5.0). These are statements of design and adherence to standards rather than reported device performance from a specific study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

None. No test set or data was used since no performance studies were conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

N/A. No ground truth was established as no performance study was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

N/A. No adjudication was performed.

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:

No. This type of study is completely irrelevant to this 510(k) submission, which is for surgical instruments, not an AI/ML-driven diagnostic or assistive technology.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This device category (surgical instruments) does not involve algorithms or AI.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

N/A. No performance data or ground truth was used.

8. The sample size for the training set:

N/A. No training set was used.

9. How the ground truth for the training set was established:

N/A. No ground truth for a training set was established.

In summary, this 510(k) submission for surgical instruments relies solely on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, without presenting any new performance data or clinical test results.

Summary

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510(k) Summary of Safety and Effectiveness

Submitter:
Date of Preparation:	January 12, 1998
Company / Institution name:	Richard Wolf Medical Instruments Corp.
FDA establishment regulation number:	14 184 79
Division name (if applicable):	N.A.
Phone number (include area code):	(847) 913-1113
Street address:	353 Corporate Woods Parkway
FAX number (include area code):	(847) 913-0924
City:	Vernon Hills
State/Province:	Illinois
Country:	USA
ZIP/Postal Code:	60061
Contact name:	Mr. Robert L. Casarsa
Contact title:	Quality Assurance Manager

Product Information:
----------------------	--

Trade name:	EPS. Instruments for Endoscopic Plastic Surgery
Model number:	See section 1. Submitted Devices
Common name:	Endoscopic and Reconstructive Plastic Surgery
Classification Name:	General and Plastic Surgery

Information on devices to which substantial equivalence is claimed:
---------------------------------------------------------------------	--

510(k) Number	Trade or proprietary or model name	Manufacturer
1 pre-enactment	1 several devices	1 Richard Wolf
2	2 EndoPlastic Instruments	2 SnowdenPencer
3	3 Endoscopic Plastic Surgery Instruments	3 Wells
4	4 Plastic & Reconstructive Surgery Instruments	4 Padgett

1.0 Description

트

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2.0 Intended Use

Endoscopes are designed to visualize anatomy through natural and man-made openings in body cavities.

The Obturator (mandrin) is used in conjunction with the sheath for atraumatic insertion into body cavities.

The Optical Retractors are used to maintain a subcutaneous space during surgical procedures, for plastic/cosmetic and reconstructive surgery. They can be combined with an endoscope to visualize the tissue and anatomic structures.

Suction/Irrigation Instruments are used to keep the operating site and the endoscope free of blood and secretion, at the same time it serves as a retractor to hold tissue out of the instrument is used in endoscopic surgery of the nose, nasal sinuses, and in endoscopic plastic surgery.

The Micro Grasping Forceps with HF are used to grasp and to coagulate small blood vessels.

The HF Coagulation Suction Aspirator suctions and coagulates while holding tissue out of the way during the endoscopic operation, e.g. of the larvnx in connection with CO2 lasers, in mediastinoscopy or in plastic surgery.

The Bipolar Coagulation suction Tube (bipolar aspiration tube) is used for aspiration and coagulation of small lesions.

Bipolar electrodes are used to coagulate and to remove or destroy tissue by the use of bipolar HF current.

{2}------------------------------------------------

3.0 Technological Characteristics

The cannula of the retraction sheath, in combination with the endoscope, allows visualization and retraction. The single port with rotatable cock allows both irrigation and suction irrigation and placed on the surgeon's non-dominant side. What does the last part of the sentence mean?

Substantial Equivalence 4.0

The devices are substantially equivalent to existing pre-enactment devices sold by Richard Wolf and 510(k) devices sold by Karl Storz.

Performance Data 5.0

No data generated. The bipolar instruments are developed to conform to the standards IEC601-2-18.

Clinical Tests 6.0

No clinical tests performed.

7.0 Conclusions Drawn

The devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manuals.

By: Robert L. Pearson

Robert L. Casarsa Quality Assurance Manager

Date: 1/8/98

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 1398 NOV

Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061

Re: K980129 Trade Name: Instruments for Endoscopic Plastic Surgery Regulatory Class: II Product Code: GCJ Dated: August 06, 1998 Received: August 07, 1998

Dear Mr. Casarsa:

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 requirement, as set forth in the Quality System Regulation (OS) 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.

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.

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Page 2 - Robert L. Casarsa

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) 594-4595. 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,

a M. Witten, PhD., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):	K980129
Device Name:	Instruments for Endoscopic Plastic Surgery (EPS)

Intended Use:

Prescription Use

Per 21 CFR 801.109

Endoscopes are designed to visualize anatomy through natural and man-made openings in body cavities.

The Obturator (mandrin) is used in conjunction with the sheath for atraumatic insertion into body cavities.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices K990129
510(k) Number

Over-The Counter

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The Micro Grasping Forceps with HF are used to grasp and to coagulate small blood vessels.

The Bipolar Coagulation suction Tube (bipolar aspiration tube) is used for aspiration and coagulation of small lesions.

Bipolar electrodes are used to coagulate and to remove or destroy tissue by the use of bipolar HF current.

Contraindications:

There are no known contraindications directly related to the attending physician must consider the general condition of the patient when determining if the application is appropriate. Refer to the current technical literature for additional instructions.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K980129

Image /page/6/Picture/10 description: The image shows a circle surrounding the text "Prescription Use Per 21 CFR 801.109". The circle is not perfectly round and appears to be hand-drawn. The text is centered within the circle.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.