(88 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, optical performance, and electrical safety of a modified laparoscope, with no mention of AI or ML capabilities.
No.
The device is a laparoscope used for visualization during saphenous vein harvesting procedures, not for therapeutic intervention in and of itself.
No
Explanation: The device is a laparoscope used for visualization during surgical procedures (saphenous vein harvesting), not for diagnosing a condition or disease. Its function is to provide visual information to the surgeon, not to interpret or analyze medical data for diagnostic purposes.
No
The device description clearly describes a physical laparoscope, which is a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Endoscopic Saphenous Vein harvesting procedures." This is a surgical procedure performed in vivo (within the living body) for visualization during surgery.
- Device Description: The device is a laparoscope, which is a surgical instrument used for viewing inside the body. It is used in conjunction with other surgical devices (cannula system, sheath).
- Anatomical Site: The device is used to view the "Saphenous Vein," which is an anatomical structure within the body.
- Input Imaging Modality: The input imaging modality is "Optical," which refers to viewing with light, consistent with a surgical endoscope.
IVD devices are used in vitro (outside the living body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description. It is a surgical instrument used for visualization during a surgical procedure.
N/A
Intended Use / Indications for Use
Intended for use in Endoscopic Saphenous Vein harvesting procedures.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Henke Sass Wolf Saphenous Vein Laparoscope is identical in terms of materials and modes of construction, optical performance and safety to the existing line of HSW 5mm Laparoscopes, differing only in working length and angle of view. The materials and basic design are identical.
For the purpose of saphenous vein harvesting, a standard 5mm laparoscope is modified to extend the working length to 300mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Saphenous Vein
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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
Testing conducted to assure safety and effectiveness include but is not limited to:
| Electrical Safety: | EN 60601-1-1, EN 601-2-10 |
|---|---|
| Electromedical System: | EN 60601-1-1 |
Proposed devices have successfully met the requirements of the above.
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.
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
§ 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
K013611 1/2
SAFETY & EFFECTIVENESS DATA SUMMARY
| Submitters Name, Address & Phone Number: | Henke Sass Wolf of America
Soroco Industrial Park, Rte. 131
529 Ashland Ave.
Southbridge, MA 01550 |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Submission Correspondent: | Lyle Howard Corporation
203 Main Street, PMB 166 |
Laparoscope, General & Plastic Surgery Classification Name: Laparoscope, General & Plastic Surgery Common / Usual Name: Henke Sass Wolf Saphemous Vein Proprietary Name: Laparoscope
Flemington, NJ 08822 Attention: Lynette Howard
1222997 Establishment Registration Number:
Class II, Reg. # 876.1500, 78 GCJ General and Plastic Classification: Surgery Accessories
Performance Standards: No performance standards have been developed for this device.
Substantial Equivalence:
The HSW Saphenous Vein Laparoscope is substantially equivalent to the Stryker Saphenous Vein Harvest Laparoscope intended use and is compatible for use with the Ethicon's Subcu-Retractor for this purpose. The HSW Saphenous Vein Laparoscope can also be used as a substitute for a standard HSW 5mm Laparoscope in similar intended use applications as outlined in Laparoscope 510(k) K941967.
The intended use of the device to which we claim substantial equivalence:
For severe cases of coronary artery disease, in which blood vessel grafts are used to bypass the site of a blocked artery, a procedure known as coronary artery bypass graft surgery (CABG) is performed. To help reduce patient trauma and cost, an endoscopic technique is used in the saphenous vein harvesting procedure. This minimally invasive approach requires only a single 3-4cm incision made medial to the knee.
1
Additional Information - Attachment III - January 28, 2002 Revised Page 15
The laparoscope in used in conjunction with Ethicon's Endo-Surgery cannula system to provide a complete visualization system. These laparoscopes were designed to be inserted in the Ethicon sheath to help view the surgical area. To facilitate this, the laparoscope working length was modified. These laparoscopes are reusable and employed in conjunction with other cleared devices, to form a complete system.
Testing conducted to assure safety and effectiveness include but is not limited to:
| Electrical Safety: | EN 60601-1-1, EN 601-2-10 |
|---|---|
| Electromedical System: | EN 60601-1-1 |
Proposed devices have successfully met the requirements of the above.
Description of the new device:
The Henke Sass Wolf Saphenous Vein Laparoscope is identical in terms of materials and modes of construction, optical performance and safety to the existing line of HSW 5mm Laparoscopes, differing only in working length and angle of view. The materials and basic design are identical.
For the purpose of saphenous vein harvesting, a standard 5mm laparoscope is modified to extend the working length to 300mm.
The HSW Saphenous Vein Laparoscope is substantially equivalent to the Stryker Saphenous Vein Harvest Laparoscope intended use and is compatible for use with the Ethicon's Subcu-Retractor for this purpose. The HSW Saphenous Vein Laparoscope can also be used as a substitute for a standard HSW 5mm Laparoscope in similar intended use applications as outlined in Laparoscope 510(k) K941967.
Intended Use:
For use in Endoscopic Saphenous Vein harvesting procedures.
Caution: Federal (USA) law restricts this device to sale, distribution, and use by, or on the order of, a physician.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 01 2002
Henke Sass Wolf of America, Inc. c/o Ms. Lynette Howard Lyle Howard Corporation 203 Main Street, PMB 166 Flemington, New Jersey 08822
Re: K013611
Trade/Device Name: Henke Sass Wolf Saphenous Vein Laparoscope Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: October 31, 2001 Received: November 5, 2001
Dear Ms. Howard:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed four becaused the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass based in 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, de neces that have been require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Errt in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Lynette Howard
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
iriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Additional Information - Attachment III - January 28, 2002 Revised Page 102
Henke Sass Wolf of America
STATEMENT OF INDICATION FOR USE
510(k) Number: K013611
Device Name:
Henke Sass Wolf Saphenous Vein Laparoscope
Indications for Use:
Intended for use in Endoscopic Saphenous Vein harvesting procedures.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Division of General, Restorative and Neurological Devices
510(k) Number K013611