(28 days)
Not Found
No
The summary describes a standard electrosurgical resectoscope and its components, with no mention of AI or ML capabilities, image processing, or performance studies related to algorithmic analysis.
Yes
The device is used for "general urological tissue resection, ablation, and excision and hemostasis of blood vessels" and "Bladder Tumor Diagnosis and Resection, Transurethral Prostatic and Bladder Biopsy, Transurethral Prostatic Resection, and Treatment of Vesical Neck Constriction," which are therapeutic procedures.
Yes
The "Intended Use" section explicitly states "Bladder Tumor Diagnosis and Resection," indicating a diagnostic function alongside a therapeutic one.
No
The device description explicitly lists hardware components (Telescope, Sheath, Bipolar Working Element, Obturator) and states it works with other hardware (Electrosurgery Systems, Controller, Bipolar Loop, Loop Cable or Cord).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures (resection, ablation, excision, hemostasis) performed on the patient's body during endoscopic surgery. IVDs are used to examine specimens from the body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a surgical instrument (Resectoscope) used for direct intervention within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
This device is a surgical instrument used for therapeutic and diagnostic procedures performed directly on the patient.
N/A
Intended Use / Indications for Use
Intended for use in patients requiring endoscopic surgery for general urological tissue resection, ablation, and excision and hemostasis of blood vessels. These procedures include Bladder Tumor Diagnosis and Resection, Transurethral Prostatic and Bladder Biopsy, Transurethral Prostatic Resection, and Treatment of Vesical Neck Constriction.
Product codes
78 FDC, FBO
Device Description
The USA Elite Bipolar Resectoscope consists of a Telescope, Sheath, Bipolar Working Element, and Obturator. The USA Elite Bipolar Resectoscope is designed to work with currently marketed Electrosurgery Systems consisting of a electrosurqical generator called the Controller, a disposable Bipolar Loop, and a reusable or disposable Loop Cable or Cord.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Preamendment & K951972
Reference Device(s)
Not Found
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)
This Special 510(k) proposes a modification in the performance specifications, dimensional specifications, materials, and labeling for The USA Elite Series Bipolar Resectoscope. The indications for use, principles of operation, the packaging materials, and the sterilization parameters of the USA Elite Bipolar Resectoscope remain the same as in the predicate device.
§ 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
MAY 0 9 2002
Bipolar Resectoscope ACMI Corporation 136 Turnpike Road Southborough, MA 02139 Special 510(k) Notification Summary of Safety and Effectiveness April 10, 2002
K021166
Page 1 of 2
510(k) Summary of Safety and Effectiveness ACMI Circon Corporation ACMI Bipolar Resectoscope
General Information
Manufacturer:
ACMI Circon Corporation 136 Turnpike Rd. Southborough, MA 01772-2104
Establishment Registration Number:
9920160
April 10, 2002
Contact Person:
John A. DeLucia VP, Quality Assurance, Regulatory Affairs and Clinical Affairs
Date Prepared:
Trade Name:
Device Description
Classification Name:
Endoscope and accessories (21CFR 876.1500)
ACMI USA Elite Series Bipolar Resectoscope
Generic/Common Name:
Predicate Devices
ACMI USA Elite Resectoscope
with Monopolar Working Element
Preamendment & K951972
Endoscope and accessories
Intended Uses
Intended for use in patients requiring endoscopic surgery for general urological tissue resection, ablation, and excision and hemostasis of blood vessels. These procedures include Bladder Tumor Diagnosis and Resection, Transurethral Prostatic and Bladder Biopsy, Transurethral Prostatic Resection, and Treatment of Vesical Neck Constriction.
Product Description
The USA Elite Bipolar Resectoscope consists of a Telescope, Sheath, Bipolar Working Element, and Obturator. The USA Elite Bipolar Resectoscope is
1
ACMI Bipolar Resectoscope ACMI Corporation 136 Turnpike Rd. Southborough, MA 01772
Special 510(k) Notification Summary of Safety and Effectiveness April 10, 2002
K021166
Page 2 of 2
designed to work with currently marketed Electrosurgery Systems consisting of a electrosurqical generator called the Controller, a disposable Bipolar Loop, and a reusable or disposable Loop Cable or Cord.
This Special 510(k) proposes a modification in the performance specifications, dimensional specifications, materials, and labeling for The USA Elite Series Bipolar Resectoscope. The indications for use, principles of operation, the packaging materials, and the sterilization parameters of the USA Elite Bipolar Resectoscope remain the same as in the predicate device.
Summary of Safety and Effectiveness
The proposed modifications for the USA Elite Series Bipolar Resectoscope, as described in this submission, are substantially equivalent to the predicate device. The proposed modification in performance specifications, dimensional specifications, materials, and labeling specifications are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the words "Public Health Service". The text is written in a simple, sans-serif font. The words are arranged on a single line, with "Public Health" appearing before "Service".
DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
MAY 0 9 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John A. DeLucia Vice President, Quality Assurance, Regulatory Affairs, Clinical Affairs ACMI Corporation Global Headquarters 136 Turnpike Road SOUTHBOROUGH MA 01772-2104 Re: K021166
Trade/Device Name: ACMI-Circon Bipolar Resectoscopes Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FDC and FBO Dated: April 10, 2002 Received: April 11, 2002
Dear Mr. DeLucia:
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.
If your device is classified (see aboye) 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); 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.
3
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), please 11 you action office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on of 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,
11 11 11
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Bipolar Resectoscope ACMI Corporation 136 Turnpike Road Southborough, MA 02139 Special 510(k) Notification Statement of Intended Use April 10, 2002
Device Name: ACMI Bipolar Resectoscope
510(k) Number:
Indications for use:
Intended for use in patients requiring endoscopic surgery for general urological intention for aboution, and excision and hemostasis of blood vessels. tissue resocion, abiation, anadder Tumor Diagnosis and Resection, Tresc procedures include Bladder Biopsy, Transurethral Prostatic Resection, and Treatment of Vesical Neck Constriction.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: X __
OR Over-the-Counter Use: ________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
lo
Nancy Crogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and