(63 days)
The Smith & Nephew HandPort System is intended to provide abdominal access to the surgeon's hand while preserving pneumoperitoneum during laparoscopic surgery. The retractor may also be used independently to provide incision retraction and to protect the wound from contamination.
The Smith & Nephew HandPort System is indicated for use in laparoscopic procedures, where entry of the surgeon's hand may facilitate the procedure, and for extraction of large specimens.
The HandPort System provides access to the abdominal cavity while maintaining pneumoperitoneum; the laparoscopic surgeon regains the tactile sense and feedback along with the increased hand-eye and instrumentation manipulation capacity of open surgery.
The standard HandPort System device consists of the following components:
- Base retractor,
- Sleeve,
- Bracelet,
- Retractor Cap, with or without Instrument Portal, and
- Sterile Lubricant
The provided text describes a 510(k) summary for the Smith & Nephew HandPort System, but it does not contain specific acceptance criteria or a detailed study report with performance metrics. The summary focuses on demonstrating substantial equivalence to a predicate device and briefly mentions three types of testing without providing detailed results or how those results meet specific criteria.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
However, I can extract the available information regarding the studies mentioned:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided document.
- Reported Device Performance:
- Bench Testing: "confirmed that the HandPort System reliably maintains pneumoperitoneum under simulated use conditions."
- Simulated Use Testing (Animal Series): "confirmed that the HandPort System provides sufficient hand access to anatomical structures while maintaining pneumoperitoneum for the duration of the surgical procedure."
- Prospective, Multicenter Clinical Trial: "confirmed the capability of the HandPort System in facilitating hand-assisted surgery in a range of surgical procedures."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Bench Testing: Sample size not specified.
- Simulated Use Testing (Animal Series): Sample size not specified. Data provenance: Animal series (details like species or number of animals not provided).
- Prospective, Multicenter Clinical Trial: Sample size not specified. Data provenance: Prospective, multicenter clinical trial. Country of origin not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified for any of the mentioned tests. The clinical trial involved "surgeons," but their number or specific qualifications (e.g., years of experience) are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified for any of the mentioned tests.
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
- This device is a surgical access system, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed. The clinical trial focused on the device's capability in facilitating hand-assisted surgery.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is a physical surgical tool, not an algorithm. Therefore, "standalone" algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The document implies clinical observation and assessment by surgeons for the clinical trial, assessing the "capability of the HandPort System in facilitating hand-assisted surgery." For bench and animal testing, the "ground truth" would be direct measurement of pneumoperitoneum maintenance and assessment of hand access to anatomical structures.
8. The sample size for the training set
- This device is a non-AI surgical tool; thus, the concept of a "training set" in the context of machine learning is not applicable.
9. How the ground truth for the training set was established
- As per point 8, this is not applicable.
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K990414
Section 9- 510k Summary of Safety and Effectiveness
| 9.1Statement | This summary of 510k safety and effectiveness information is being submitted inaccordance with the requirements of SMDA 1990 and CFR 807.92 |
|---|---|
| 9.2Submitter | Smith and Nephew Endoscopy, Inc.Endoscopy Division130 Forbes BoulevardMansfield, Ma. 02048 |
| 9.3CompanyContact | Amy WaltersGroup Manager, RA/QA/Clinical(508) 261-3776 |
| 9.4DeviceName | Proprietary Name: HandPort SystemCommon Name: Extended Laparoscopic Device and AccessoriesClassification Name: Endoscopic accessories(78 GCJ)Laparoscopic accessories (85 HET) |
| 9.5PredicateLegallyMarketedDevice | Dexterity PneumoSleeve (K962147), cleared on July 9, 1996 |
| 9.6DeviceDescription | The HandPort System provides access to the abdominal cavity while maintainingpneumoperitoneum; the laparoscopic surgeon regains the tactile sense andfeedback along with the increased hand-eye and instrumentation manipulationcapacity of open surgery.The standard HandPort System device consists of the following components:1. Base retractor,2. Sleeve,3. Bracelet,4. Retractor Cap, with or without Instrument Portal, and5. Sterile Lubricant |
| 9.7Intended Use | The Smith & Nephew HandPort System is intended to provide abdominal accessto the surgeon's hand while preserving pneumoperitoneum during laparoscopicsurgery. The retractor may be used independently to provide incision retractionand to protect the wound from contamination. |
| 9.8 DeviceIndications | The Smith & Nephew HandPort System is indicated for use in laparoscopicprocedures, where entry of the surgeon's hand may facilitate the procedure, andfor extraction of large specimens. |
| 9.9SubstantialEquivalence | Predicate Device Comparison:The HandPort System is substantially equivalent to the currently marketedExtended Laparoscopic Device: Dexterity PneumoSleeve. The devices are similarin materials, design, intended use, and indications for use:Both devices are sterile, and intended for single use. Both devices are intended to provide abdominal access to the surgeon'shand while preserving pneumoperitoneum during laparoscopic surgery. With both devices, the retractor may also be used independently toprovide incision retraction and to protect the wound fromcontamination during both laparoscopic and open surgery. Testing Summary:Bench testing confirmed that the HandPort System reliably maintainspneumoperitoneum under simulated use conditions.Simulated use testing in an animal series confirmed that the HandPort Systemprovides sufficient hand access to anatomical structures while maintainingpneumoperitoneum for the duration of the surgical procedure.A prospective, multicenter clinical trial confirmed the capability of the HandPortSystem in facilitating hand-assisted surgery in a range of surgical procedures. |
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Applicant Amy Walters
Date 3/29/99
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 1939
Ms. Amy L. Walters Group Manager, Regulatory Affairs, Quality Assurance and Clinical Smith & Nephew, Inc. Endoscopy Division 130 Forbes Boulevard Mansfield, Massachusetts 02048
Re: K990414
Trade Name: Smith & Nephew HandPort System Regulatory Class: II Product Code: GCJ Dated: February 5, 1999 Received: February 10, 1999
Dear Ms. Walter:
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 (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 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.
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Page 2 - Ms. Amy L. Walters
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) 594-4595. 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,
Celia M. Witten, Ph.D., 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): K990414
Device Name: Smith & Nephew HandPort System
Indications For Use:
The Smith & Nephew HandPort System is indicated for use in laparoscopic procedures, where entry of the surgeon's hand may facilitate the procedure, and for extraction of large specimens.
Intended Use:
The Smith & Nephew HandPort System is intended to provide abdominal access to the surgeon's hand while preserving pneumoperitoneum during laparoscopic surgery. The retractor may also be used independently to provide incision retraction and to protect the wound from contamination.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
(Division Division of General Re 510(k) Number
§ 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.