(295 days)
1 pre-enactment, 2, 3, 4
Not Found
No
The document describes a set of traditional surgical instruments used in endoscopic plastic surgery. There is no mention of AI, ML, or any computational processing of data for analysis or decision-making.
Yes.
The device's components like Micro Grasping Forceps with HF, HF Coagulation Suction Aspirator, Bipolar Coagulation suction Tube, and Bipolar Coagulation Instrument are explicitly used for therapeutic purposes like grasping, coagulating, and removing/destroying tissue during surgical procedures.
No
The document describes instruments primarily used for visualization and surgical manipulation (e.g., retraction, grasping, coagulation, suction/irrigation) during endoscopic procedures, not for reaching a diagnosis. While some instruments allow visualization, this is for surgical guidance, not for diagnosing a condition.
No
The device description explicitly lists physical instruments such as endoscopes, sheaths, retractors, forceps, and electrodes, indicating it is a collection of hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the devices as being used in vivo (within the body) for visualization, surgical access, tissue manipulation, and coagulation during endoscopic procedures. IVD devices are used in vitro (outside the body) to examine specimens derived from the human body.
- Device Description: The description lists instruments like endoscopes, cannulas, retractors, forceps, and electrodes, all of which are used directly on or within the patient.
- Anatomical Site: The anatomical sites mentioned are all within the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
The devices described are surgical instruments used for endoscopic procedures.
N/A
Intended Use / Indications for Use
Endoscopes are designed to visualize anatomy through natural and man-made openings in body cavities.
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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body cavities, operating site, nose, nasal sinuses, larynx, subcutaneous tissue
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)
No data generated. The bipolar instruments are developed to conform to the standards IEC601-2-18.
No clinical tests performed.
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.
1 pre-enactment, 2, 3, 4
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
Not Found
§ 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.
0
. ... ..
ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺪﻳﺮ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ
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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
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).
트
1
2.0 Intended Use
Endoscopes are designed to visualize anatomy through natural and man-made openings in body cavities.
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-facelift, 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 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.
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.
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
3
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.
4
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
5
| 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.
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.
(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
6
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.
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.