(88 days)
Not Found
No
The description focuses on mechanical and optical features of a flexible endoscope and does not mention any AI/ML components or functionalities.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for therapeutic and diagnostic procedures."
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for therapeutic and diagnostic procedures."
No
The device description clearly outlines physical hardware components such as a polyurethane outer covering, cable compensation system, torque-stabilization shaft, light transmission, ports, and a detachable light guide. It also describes mechanical features like deflection sections and control levers. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The ACMI USA Series™ DUR™-8 and DUR™-8 Elite are flexible endoscopes used for direct visualization and therapeutic procedures within the body (intrarenal collecting system and bile ducts). They are used in vivo (within a living organism), not in vitro (in a test tube or laboratory setting).
- Lack of Specimen Analysis: The description focuses on the physical characteristics and functionality of the endoscope for internal examination and procedures, not on the analysis of biological specimens.
Therefore, based on the provided information, this device falls under the category of a surgical or diagnostic instrument used for internal examination and procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ACMI USA Series™ DUR™-8 and DUR™-8 Elite (DUR™-8E) Flexible Ureteropyeloscope and Choledochoscope are indicated for therapeutic and diagnostic procedures in the entire intrarenal collecting system. The DUR™-8 and DUR™-8E are also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.
Product codes
78 FGB, FBN
Device Description
Both the DUR™-8 and DUR™-8E are non-sterile, reusable flexible fiberoptic endoscopes. They feature a lubricious polyurethane outer covering, a patented cable compensation system, a patented torque-stabilization shaft construction, duel light transmission, a rotating light post, luer lock irrigation and biopsy ports, and a detachable light guide. The optics, illumination carriers, working channel, manufacturing methods and specifications of both devices are identical.
The DUR™-8E is a modification of the DUR™-8 designed to provide the clinician with greater control over the distal tip of the endoscope. The DUR™-8 has a passive deflection section, while the DURTM-8 Elite has an actively controllable section proximal to the primary active deflection section. A secondary deflection control lever has been added to the head of the DURTM-8 Elite.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intrarenal collecting system, bile ducts
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)
K012951, K972926, K971977, K012925
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary for the ACMI USA Series™ DUR™-8 and DUR™-8 Elite Flexible Ureteropyeloscope and Choledochoscope
1. Sponsor
ACMI Corporation 136 Turnpike Road Southborough, MA 01771-2104
Contact Person: Terrence E. Sullivan Telephone: 508-804-2739 Date Prepared: October 4, 2002
2. Device Name
| Proprietary Name: | ACMI Corporation USA Series™ DUR™-8 and
DUR™-8 Elite Flexible Ureteropyeloscope and
Choledochoscope |
|----------------------|-----------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Flexible endoscope |
| Classification Name: | Endoscope and accessories |
Predicate Devices 3.
- ACMI APN™-2 (K012951)
- Karl Storz MVM 7.5 Fr. Flexible Choledochoscope (K972926)
- Karl Storz 15.5 Fr. Flexible Choledocho-Fiberscope (K971977) ●
- ACMI DURTM-8 (K012925)
4. Device Description
Both the DUR™-8 and DUR™-8E are non-sterile, reusable flexible fiberoptic endoscopes. They feature a lubricious polyurethane outer covering, a patented cable compensation system, a patented torque-stabilization shaft construction, duel light transmission, a rotating light post, luer lock irrigation and biopsy ports, and a detachable light guide. The optics, illumination carriers, working channel, manufacturing methods and specifications of both devices are identical.
The DUR™-8E is a modification of the DUR™-8 designed to provide the clinician with greater control over the distal tip of the endoscope. The DUR™-8 has a passive deflection section, while the DURTM-8 Elite has an actively controllable
1
Ka23358
section proximal to the primary active deflection section. A secondary deflection control lever has been added to the head of the DURTM-8 Elite.
ട. Intended Use
The ACMI USA Series™ DUR™-8 and DUR™-8 Elite (DUR™-8E) Flexible Ureteropyeloscope and Choledochoscope are indicated for therapeutic and diagnostic procedures in the entire intrarenal collecting system and are also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.
6. Technological Characteristics and Substantial Equivalence
ACMI Corporation bases the claim of equivalence on similarities in indications for use, design, materials, technological characteristics, and operational characteristics.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stylized heads.
Public Health Service
JAN 0 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Terrence Sullivan Corporate Quality Systems Manager ACMI Corporation 136 Turnpike Road SOUTHBOROUGH MA 01772
Re: K023358
Trade/Device Name: USA Series™ DUR-8™ Elite and USA Series DUR™-8 Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FGB and FBN Dated: October 4, 2002 Received: October 7, 2002
Dear Mr. Sullivan:
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. 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 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 contact the 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 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,
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
Page 2
4
Indications for Use Statement
510(k) Number (if known):
ACMI USA Series™ DUR™-8 and DUR™-8 Elite (DUR™-8E) Flexible Device Name: Ureteropyeloscope and Choledochoscope
Indications For Use:
The ACMI USA Series™ DUR™-8 and DUR™-8 Elite (DUR™-8E) Flexible Ureteropyeloscope and Choledochoscope are indicated for therapeutic and diagnostic procedures in the entire intrarenal collecting system. The DUR™-8 and DUR™-8E are also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancye Brogdon
(Division Sign-Off)
Division of Reproductive, **Abdominal**,
and Radiological Devices
510(k) Number [K022358](https://510k.innolitics.com/search/K022358)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________