(58 days)
The Henke Sass Wolf of America HSW Bariatric Laparoscope is intended to be used in general laparoscopic surgery. Laparoscopic surgery is a means of performing diagnostic and therapeutic surgical procedures intra-abdominally using equipment that minimizes surgical invasiveness. Rather than creating large incisions to gain access to surgical sites, surgeons view inside the body and operate by using instruments inserted through small skin punctures (inserted through the laparoscope or through another small incision). This includes, but is not limited to such uses as gallbladder and appendix removal, hernia repair, and examination of the abdominal cavity, appendix, gallbladder, and liver.
Bariatric laparoscopes are intended to be used to perform surgical procedures on morbidly obese segments of the patient population.
The Henke Sass Wolf of America's Bariatric Laparoscope is identical in terms of materials and modes of construction, optical performance and safety to Henke Sass Wolf GmbH HSW Laparoscopy Set - K941967 and the Stryker - K993045. This Bariatric version is longer (up to 550mm) so that it is capable of performing the same types of procedures on morbidly obese segments of the patient population.
Diameter: 5mm - 10mm
Length: 280mm to 550mm
Direction of View: 0, 30, 45 Degrees
Field of View: 75 Degrees
Shaft: 300 Series Stainless Steel
Body: Stainless Steel
Sidearm: Stainless Steel
Eyepiece: P.E.E.K.
Lenses: Glass or Sapphire
Adapters for connection to all conventional light-guides are supplied as standard.
The device is intended to be sterilized prior to use. The Bariatric Laparoscopes are designed to facilitate cleaning and disinfection as were the predicate devices. There is no difference in design and material that would impact the sterilization validation conducted for the HSW predicate device.
Instructions for cleaning and sterilization are included in the instructions for use. Sterilization and disinfection validation for predicate devices included EtO, Steris, and Sterrad is performed to assure an SAL of 10-6 per AAMI / ISO Standards.
The provided text is a 510(k) premarket notification for a medical device, specifically a bariatric laparoscope. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with detailed acceptance criteria and performance metrics in the way that a new, high-risk device might.
Therefore, much of the requested information about a study that proves the device meets acceptance criteria (e.g., sample sizes for test/training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) is not applicable to this type of regulatory submission or the information presented in the document.
The document primarily states that the proposed device is substantially equivalent to existing predicate devices based on design, materials, manufacturing methods, and intended use. The "acceptance criteria" here are essentially the requirements for demonstrating substantial equivalence as per FDA regulations.
Here's an attempt to answer the questions based only on the provided text, while acknowledging the limitations for a 510(k) submission:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, "acceptance criteria" are not typically stated as quantified performance targets but rather as demonstrating equivalence to predicate devices. The "performance" is implicitly deemed equivalent if the device meets the characteristics and testing mentioned.
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device Performance/Compliance |
|---|---|
| Intended Use Equivalence: Same indications for use as predicate devices. | The Henke Sass Wolf Bariatric Laparoscope shares the same general laparoscopic surgery indications as the predicate devices (gallbladder/appendix removal, hernia repair, examination of abdominal cavity, appendix, gallbladder, and liver). It adds an intention to be used on morbidly obese patients, which is also an indication for one of the predicate devices (Stryker Bariatric Laparoscopes, K993045). |
| Technological Characteristics Equivalence: Similar design, materials, and operational principles. | The device is "identical in terms of materials and modes of construction, optical performance and safety" to the Henke Sass Wolf GmbH HSW Laparoscopy Set (K941967) and the Stryker (K993045). It is longer (up to 550mm) to accommodate bariatric procedures, but this is presented as a variation of an existing feature (length) to serve a specific patient population, which is also covered by one of the predicate devices. The specific dimensions, materials (stainless steel, PEEK, glass/sapphire), and direction/field of view are also specified and implicitly align with industry standards or predicate features. |
| Safety Testing: Compliance with relevant safety and sterilization standards. | Biological Evaluation: Successfully met requirements of ISO 10993-1, ISO 10993-5, ISO 10993-12. Electrical Safety: Successfully met requirements of IEC 601-2-18 (BF or CF applied part). Sterilization: Successfully met AAMI/ISO Standards for Sterilization of Medical Devices. Validation conducted for predicate device included EtO, Steris, and Sterrad to assure an SAL of 10^-6. No difference in design/material that would impact this validation. |
| No New Issues of Safety or Effectiveness: The device does not raise new questions of safety or effectiveness. | "The HSW Bariatric Laparoscope does not introduce new issues when compared to its predicate devices or uses." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission for a medical device (laparoscope), not an AI/software device requiring a "test set" of clinical data for performance evaluation in the typical sense. The "testing" referred to是在工程和生物相容性层面上进行的物理和材料测试，而不是基于临床数据集的性能评估。
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. See point 2.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See point 2.
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
Not applicable. This device is a physical surgical instrument (laparoscope), not an imaging AI diagnostic aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable in the context of clinical performance data. The "ground truth" for this submission revolves around established engineering standards (e.g., ISO for biocompatibility, IEC for electrical safety, AAMI/ISO for sterilization) and the established characteristics and safety profile of the predicate devices.
8. The sample size for the training set
Not applicable. This device is a physical surgical instrument, not an AI/software device requiring a "training set."
9. How the ground truth for the training set was established
Not applicable. See point 8.
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41
MAR 2 4 2005
Henke Sass Wolf of America
44 Southbridge Rd.
KOSO 163
SAFETY & EFFECTIVENESS DATA SUMMARY
| Dudley, MA 01571 | |
|---|---|
| Submission Correspondent: | Lyle Howard Corporation |
| 203 Main Street, PMB 166 | |
| Flemington, NJ 08822 | |
| Attention: Lynette Howard | |
| Classification Name: | Endoscope & Accessories |
| Common / Usual Name: | Bariatric Laparoscope |
| Proprietary Name: | Henke Sass Wolf Bariatric Laparoscope |
| Establishment Registration Number: | 1222997 |
| Classification: | Class II, Reg. # 876.1500, GCJ Gastroenterology - Urology |
Performance Standards: No performance standards have been developed for this device.
Substantial Equivalence:
Submitters Name, Address & Phone Number:
The Henke Sass Wolf of America Bariatric Laparoscopes are substantially equivalent to the Henke Sass Wolf GmbH - K941967 and the Stryker -K993045 in design, materials, methods of construction and intended use.
The intended use of the devices to which we claim substantial equivalence:
The Henke Sass Wolf of America HSW Laparoscopy Set (K941967) is intended to be used in general laparoscopic surgery. Laparoscopic surgery is a means of performing diagnostic and therapeutic surgical procedures intraabdominally using equipment that minimizes surgical invasiveness. Rather than creating large incisions to gain access to surgical sites, surgeons view inside the body and operate by using instruments inserted through small skin punctures (inserted through the laparoscope or through another small incision). This includes, but is not limited to such uses as gallbladder and appendix removal, hernia repair, and examination of the abdominal cavity, appendix, gallbladder, and liver.
1/3
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KOSO163
The Stryker Bariatric Laparoscopes (K993045) are intended to be used by surgeons in diagnostic and therapeutic procedures. Laparoscopic minimally invasive procedures are performed in the abdominal cavity by means of small skin punctures that allow the insertion of the laparoscope and laparoscopic instruments. This includes, but is not limited to such uses as gallbladder and appendix removal, hernia repair, gastric bypass, laparoscopic Nissen and examination of the abdominal cavity, appendix, gallbladder and liver.
Bariatric laparoscopes allow surgeons to perform procedures on morbidly obese segments of the patient population.
Testing conducted to assure safety and effectiveness include but is not limited to:
Biological Evaluation of Medical Devices - ISO 10993-1, ISO 10993-5, ISO 10993-12 Electrical Safety Requirements as per IEC 601-2-18 as a type BF or Type CF applied as part of medical electrical equipment. AAMI / ISO Standards for Sterilization of Medical Devices
Proposed devices have successfully met the requirements of the above.
Description of the new device:
The Henke Sass Wolf of America's Bariatric Laparoscope is identical in terms of materials and modes of construction, optical performance and safety to Henke Sass Wolf GmbH HSW Laparoscopy Set - K941967 and the Stryker - K993045. This Bariatric version is longer (up to 550mm) so that it is capable of performing the same types of procedures on morbidly obese segments of the patient population.
| Diameter | 5mm - 10mm |
|---|---|
| Length | 280mm to 550mm |
| Direction of View | 0, 30, 45 Degrees |
| Field of View | 75 Degrees |
| Shaft | 300 Series Stainless Steel |
| Body | Stainless Steel |
| Sidearm | Stainless Steel |
| Eyepiece | P.E.E.K. |
| Lenses | Glass or Sapphire |
Specifications / Materials:
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Adapters for connection to all conventional light-guides are supplied as standard.
The device is intended to be sterilized prior to use. The Bariatric Laparoscopes are designed to facilitate cleaning and disinfection as were the predicate devices. There is no difference in design and material that would impact the sterilization validation conducted for the HSW predicate device.
Instructions for cleaning and sterilization are included in the instructions for use. Sterilization and disinfection validation for predicate devices included EtO, Steris, and Sterrad is performed to assure an SAL of 10-6 per AAMI / ISO Standards.
Intended Use:
The Henke Sass Wolf of America HSW Bariatric Laparoscope is intended to be used in general laparoscopic surgery. Laparoscopic surgery is a means of performing diagnostic and therapeutic surgical procedures intraabdominally using equipment that minimizes surgical invasiveness. Rather than creating large incisions to gain access to surgical sites, surgeons view inside the body and operate by using instruments inserted through small skin punctures (inserted through the laparoscope or through another small incision). This includes, but is not limited to such uses as gallbladder and appendix removal, hernia repair, and examination of the abdominal cavity, appendix, gallbladder, and liver.
Bariatric laparoscopes are intended to be used to perform surgical procedures on morbidly obese segments of the patient population.
Caution: Federal (USA) law restricts this device to sale, distribution, and use by, or on the order of, a physician.
Safety and Efficacy Information:
There are no changes in the material used in the manufacturing process, which would affect the Safety and Effectiveness of the proposed device.
The HSW Bariatric Laparoscope does not introduce new issues when compared to its predicate devices or uses. Therefore, the HSW Bariatric Laparoscope is substantially equivalent to its predicate devices.
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Image /page/3/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling waves or curves, stacked on top of each other. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 2005
Henke Sass Wolf of America, Inc. c/o Ms. Lynette L. Howard Lyle Howard Corporation 203 Main Street, PMB 166 Flemington, New Jersey 08822
Re: K050163
Trade/Device Name: Henke Sass Wolf Bariatric Laparoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: March 3, 2005 Received: March 4, 2005
Dear Ms. Howard:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (o eonimores provision in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and ocometherefore, market the device, subject to the general controls provisions of the Act. The r ou may) and survisions of the Act include requirements for annual registration. Iisting 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 11 70ar artise 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 docs 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 forth 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.
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Page 2 - Ms. Lynette L. Howard
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo lotter will as a maing of substantial equivalence of your device of your device to a legally prematics noticate 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), please 11 you a the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Marcharts, 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/industry/support/index.html.
Sincerely yours,
Ech
Miriam C. Provost, h.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): k (150163
Device Name: Henke Sass Wolf Bariatric Laparoscope
Indications For Use:
The Henke Sass Wolf of America HSW Bariatric Laparoscope is intended to be used in general laparoscopic surgery. Laparoscopic surgery is a means of performing diagnostic and therapeutic surgical procedures intra-abdominally using equipment that minimizes surgical invasiveness. Rather than creating large incisions to gain access to surgical sites, surgeons view inside the body and operate by using instruments inserted through small skin punctures (inserted through the laparoscope or through another small incision). This includes, but is not limited to such uses as gallbladder and appendix removal, hernia repair, and examination of the abdominal cavity, appendix, gallbladder, and liver.
Bariatric laparoscopes are intended to be used to perform surgical procedures on morbidly obese segments of the patient population.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elich
Page 1 of
KOS0163
47
§ 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.