(106 days)
Resectoscopes are used for endoscopically controlled ablation of tissue. They are used for examination, diagnosis and/or therapy in conjunction with endoscopic accessories in the various medical disciplines such as Urology and Gynecology.
Resectoscopes are used in transuretheral resection of the prostate (TURP) and in transuretheral resection of bladder tumors (TURB). They consist of:
- · Endoscope
- · Resectoscope sheaths with obturators
- · Working Element
- · Electrodes
The devices are reusable and provided nonsterile. They must be cleaned and sterilized before use.
The body contact materials are surgical grade stainless steel which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
The provided text is a 510(k) summary for the AED Resectoscope, and it does not contain the detailed information typically found in a study proving a device meets acceptance criteria. This document focuses on demonstrating substantial equivalence to predicate devices, rather than independent performance studies with specific acceptance criteria and detailed statistical analysis.
Therefore, many of the requested fields cannot be filled from the given text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Conformance to ISO 8600-4:1997, 8600-1:2005, 8600-3:1997, 8600-5:2005, 8600-6:2005 and IEC 60601-2-2 2006, IEC 60601-2-18 Edition 3.0 2009-08, IEC 60601-2-2 Edition 5.0 2009-02 and IEC 60601-2-2:2009. | The devices conform to these standards. |
| Basic functional characteristics are substantially equivalent to predicate devices. | Design analysis and comparison confirm that basic functional characteristics are substantially equivalent to the predicate devices cited and raise no new issues of safety and effectiveness. |
| Biocompatibility of body contact materials. | Body contact materials (surgical grade stainless steel) have a long history of biocompatibility for human use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document describes a "design analysis and comparison" rather than a clinical or performance test set involving patient data.
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 / Not provided. Ground truth establishment is typically for diagnostic devices or those requiring expert interpretation. This device is a surgical instrument. The evaluation here is against engineering standards and comparison to predicate devices, not against a "ground truth" established by experts in a clinical scenario.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. This relates to clinical studies with expert reviewers, which is not the type of evaluation described.
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 resectoscope, a surgical instrument, not an AI-powered diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical surgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. For this type of device, the "truth" is typically adherence to engineering specifications, safety standards, and functional equivalence to legally marketed predicate devices, not a clinical "ground truth" derived from patient outcomes or pathology.
8. The sample size for the training set
- Not applicable. This relates to machine learning models, which are not involved here.
9. How the ground truth for the training set was established
- Not applicable. (See point 8).
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K102663
pg 1 of 2
ATTACHMENT B
510(k) Summary of Safety and Effectiveness
September 13, 2010
DEC 30 2010
Submitter:
Date:
National Advanced Endoscopy Devices, Inc. 22134 Sherman Way Canoga Park, CA 91303 Telephone: 818.227.2720 818.227.2724 Fax: Contact Person: Gayle M. Butler
Compliance Manager
Product: Trade Name: Classification: Common Name: Classification Name:
AED Resectoscopes Class II Resectoscope Resectoscope (FJL, 21 CFR 876.1500) Resectoscope, Working Element (FDC, 21 CFR 876.1500) Electrode, Electrosurgical, Active, Urological (FAS, 21 CFR 876.4300)
Predicate Devices: Resectoscope E-Line, Richard Wolf, K980302 Resectoscopes, Karl Storz, K954050
Device Description: Resectoscopes are used in transuretheral resection of the prostate (TURP) and in transuretheral resection of bladder tumors (TURB). They consist of:
- · Endoscope
- · Resectoscope sheaths with obturators
- · Working Element
- · Electrodes
The devices are reusable and provided nonsterile. They must be cleaned and sterilized before use.
The body contact materials are surgical grade stainless steel which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use. .
{1}------------------------------------------------
K 102663
pg 2 of 2
Intended Use:
Resectoscopes are used for endoscopically controlled ablation of tissue. They are used for examination, diagnosis and/or therapy in conjunction with endoscopic accessories in the various medical disciplines such as Urology and Gynecology.
Comparison to Predicate Device:
Comparison to Predicate Device: Design analysis and comparison confirm that basic functional characteristics are substantially equivalent to the predicate devices cited and raise no new issues of safety and effectiveness.
Performance Standards: The devices conform to ISO 8600-4:1997, 8600-1:2005, 8600-3:1997, 8600-5:2005, 8600-6:2005 and IEC 60601-2-2 2006, IEC 60601-2-18 Edition 3.0 2009-08, IEC 60601-2-2 Edition 5.0 2009-02 and IEC 60601-2-2:2009.
Conclusion: Based on the technical information provided. intended use and performance information provided in this premarket notification, AED Resectoscopes have been shown to be substantially equivalent to the current legally marketed predicate devices.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of a bird in flight. The bird is composed of three curved lines, representing the three branches of government.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Gayle Butler Compliance Manager National Advanced Endoscopy Devices, Inc. 22134 Sherman Way CANOGA PARK CA 91303
DEC 30 2010
Re: K102663
Trade/Device Name: AED Resectoscopes consisting of working elements, standard and continuous irrigation, resectoscope sheaths, coagulation and cutting electrodes, standard timberlake (deflecting) and visual obturators and endoscopes.
Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscopes and accessories Regulatory Class: II Product Codes: FJL, FDC and FAS Dated: December 21, 2010 Received: December 27, 2010
Dear Ms. Butler:
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 to devices that have been reclassified 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). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related
{3}------------------------------------------------
Page 2
adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default:htm.
Sincerely vours.
Hubert Lemmer MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ATTACHMENT A
DEC 3 0 2010
Page 1 of . 1
INDICATIONS FOR USE
510(k) Number (if known): K /o 2 6 6 3
Device Name: AED Resectoscopes consisting of working elements, standard and continuous irrigation, resectoscope sheaths, coagulation and cutting electrodes, standard timberlake (deflecting) and visual obturators and endoscopes.
Indications for Use: Resectoscopes are used for endoscopically controlled ablation of tissue. They are used for examination, diagnosis and/or therapy in conjunction with endoscopic accessories in the various medical disciplines such as Urology and Gynecology.
Prescription Use __ X (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (Per 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number X102663
§ 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.