(315 days)
No
The device description lists standard surgical instruments and there is no mention of AI, ML, or image processing capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly states that the ESDP instrument set is used for "therapeutic procedures of subfascial veins". Additionally, the devices are used for harvesting veins for surgical procedures, which are therapeutic interventions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the ESDP instrument set is used for "diagnostic" procedures of subfascial veins.
No
The device description explicitly lists physical instruments such as operating telescopes, endoscopic operating tubes, forceps, and scissors, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside the body.
- Device Function: The description clearly states that this instrument set is used for surgical procedures (harvesting and dissecting veins) that take place within the body (endoscopic subfascial).
- Intended Use: The intended use is for minimally invasive preparation and harvesting of veins for surgical procedures, and for visualization, diagnostic, and therapeutic procedures of subfascial veins. These are all in vivo (within the living organism) procedures.
- Device Components: The components listed (telescopes, operating tubes, forceps, scissors, dissector) are surgical instruments, not diagnostic reagents or analyzers used for testing samples.
Therefore, this device falls under the category of surgical instruments used for therapeutic and diagnostic procedures performed directly on the patient, not for testing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The ESHV (Endoscopic Subfascial Harvesting of Veins) instrument set is used for minimally invasive preparation and harvesting of the veins for use in cardiac and vascular surgical procedures. The intervention takes place under sterile conditions.
The Veins dissector (stripper) is used for the blunt preparation of tubular structures, specifically for the free-preparation of vessels, e.g. the vein saphena magma.
The ESDP (Endoscopic Subfascial Discision of Perforating Veins) instrument set is used for minimally invasive visualization, diagnostic, and therapeutic procedures of subfascial veins in the lower extremities, e.g. the saphenous vein. The intervention takes place under sterile conditions.
Product codes
78 GCJ
Device Description
The Instruments for endoscopic subfascial Harvesting of Veins (ESHV) and Endoscopic Subfascial Discision of Perforating Beins (ESDP) consists of operating telescopes, endoscopic operating tubes, laser guide, hook knife, various monopolar and bipolar grasping forceps and scissors, and veins dissector (stripper).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Veins, lower extremities
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)
Performance data not generated.
No clinical tests performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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AUG 27 1998
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Image /page/0/Picture/1 description: The image shows a handwritten number sequence, "16973943". The numbers are written in a dark ink, and the background is white. The numbers are slightly smudged, but they are still legible. There are some other markings on the left side of the image.
RICH ARD INSTRUMENTS CORPORATION
Image /page/0/Picture/3 description: The image shows a black and white square with a stylized symbol inside. The symbol appears to be a combination of lines and shapes, possibly representing a character or logo. The image quality is somewhat degraded, with some pixelation and blurring around the edges of the square and the symbol.
F
510(k) Summary of Safety and Effectiveness
| Submitter: | | | | Date of Preparation:
October 10, 1997 | | |
|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-----------------|----------------------------------------------------|-----------------------------------------------------|--|--|
| 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: | Instruments for Endoscopic Subfascial Harvesting of Veins (ESHV) and Endoscopic Subfascial Discision of Perforating Veins (ESDP) | | | Model number:
8781, 8393, 8394 and others | | |
| Common name:
Operating Tubes. Operating Telescope
Laser Guide. Knife | | | Classification Name:
Endoscopes and Accessories | | | |
| Information on devices to which substantial equivalence is claimed: | | | | | | |
| 510(k) Number | Trade or proprietary or model name | Manufacturer | | | | |
| 1 K964258 | 1 Instruments for Endoscopic Subfascial Discision of Perforating Veins "ESDP", Model 8781 | 1 Richard Wolf | | | | |
| 2 | 2 See section 3, Equivalent Devices | 2 | | | | |
| 3 | 3 | 3 | | | | |
| 4 | 4 | 4 | | | | |
1
1.0 Description
The Instruments for endoscopic subfascial Harvesting of Veins (ESHV) and Endoscopic Subfascial Discision of Perforating Beins (ESDP) consists of operating telescopes, endoscopic operating tubes, laser guide, hook knife, various monopolar and bipolar grasping forceps and scissors, and veins dissector (stripper).
2.0 Intended Use
The ESHV (Endoscopic Subfascial Harvesting of Veins) instrument set is used for minimally invasive preparation and harvesting of the veins for use in cardiac and vascular surgical procedures. The intervention takes place under sterile conditions.
The Veins dissector (stripper) is used for the blunt preparation of tubular structures, specifically for the free-preparation of vessels, e.g. the vein saphena magma.
The ESDP (Endoscopic Subfascial Discision of Perforating Veins) instrument set is used for minimally invasive visualization, diagnostic, and therapeutic procedures of subfascial veins in the lower extremities, e.g. the saphenous vein. The intervention takes place under sterile conditions.
3.0 Technological Characteristics
There are no new technological changes on the submitted devices compared to the existing devices. The EDHV endoscope, tubes, and instruments are longer than the ESDP.
4.0 Substantial Equivalence
The submitted devices are substantially equivalent to existing pre-enactment and 510(k) devices sold by Richard Wolf and competitors.
5.0 Performance Data
Performance data not generated.
- 6.0 Clinical Tests No clinical tests performed.
7.0 Conclusions Drawn
These devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manual.
By: Robert J. Casassa
Robert L. Casarsa Quality Assurance Manager
Date: Oct 10, 97
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol featuring three human profiles connected by flowing lines, representing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 27 1998
Mr. Robert L. Casarsa Manager of Quality Assurance Richard Wolf Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, IL 60064
Re : K973943 Instruments for Endoscopic Subfacial Harvesting of Veins and Endoscopic Subfacial Discision of Perforating Veins Regulatory Class: II (two) Product Code: 78 GCJ Dated: June 23, 1998 Received: June 24, 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 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, Druq, 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 Requlations, 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
3
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.
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) 594-4648. 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, 2 Misbrandinq by reference to premarket notification² (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph. D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K973943 Instruments for Endoscopic Subfascial Harvesting of Veins Device Name: And Endoscopic Subfascial Discision of Perforating Veins
Intended Use:
The ESHV (Endoscopic Subfascial Harvesting of Veins) instrument set is used for minimally invasive preparation and harvesting of the veins for use in cardiac and vascular surgical procedures. The intervention takes place under sterile conditions.
The Veins dissector (stripper) is used for the blunt preparation of tubular structures. specifically for the free-preparation of vessels, e.g. the vein saphena magma.
The ESDP (Endoscopic Subfascial Discision of Perforating Veins) instrument set is used for minimally invasive visualization, diagnostic, and therapeutic procedures of subfascial veins in the lower extremities, e.g. the saphenous vein. The intervention takes place under sterile conditions.
Contraindications;
There are no known contraindications directly related to the product. 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.
Combinations:
Auxiliary instruments from 3.5 mm to 5.5 mm diameter are used through the operation channel. Refer to the corresponding auxiliary instruction manuals.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation
Bera R. Kemper a
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K973943
Prescription Use
Per 21 CFR 801.109