(19 days)
Not Found
No
The summary describes a semi-rigid endoscope with optical imaging fibers and mechanical components. There is no mention of AI, ML, image processing, or any software-based analysis of the optical data. The changes described relate to sterilization, materials, and manufacturing processes.
Yes
The device is described as performing both diagnostic and therapeutic procedures, and mentions the use of accessories like stone baskets and lithotripter probes, which are therapeutic in nature.
Yes
The "Intended Use / Indications for Use" states the device is intended for "examination/operation of the urinary tract" and to "perform various diagnostic and therapeutic procedures." Examination and diagnosis are key components of diagnostic devices.
No
The device description clearly outlines physical components like a metal shaft, working channels, eyepiece, optical fibers, and a distal lens, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "examination/operation of the urinary tract" and performing "diagnostic and therapeutic procedures" within the body. This is an in-vivo (within a living organism) procedure.
- Device Description: The device is a semi-rigid endoscope with working channels for inserting instruments. This is a surgical/interventional device, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) in vitro (in a lab setting). The device is used for direct visualization and intervention within the patient's body.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used to directly interact with the human body.
N/A
Intended Use / Indications for Use
The ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes (MR-6A) are intended for The examination/operation of the urinary tract, and using additional accessories, to the claimmation operation of the exapentic procedures. These devices are marketed as perform various diagnostic and mering, disinfecting and sterilization are included in reusable devices, member for creaming, excition 7.0, "Cleaning, Disinfection, and Sterilization".
Product codes (comma separated list FDA assigned to the subject device)
FGB
Device Description
Like the predicate ACMI® MR-Series Ureteroscopes, the ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes are semi-rigid endoscopes with two working channels. Flexible accessories such as stone baskets, retrievers, forceps, electrohydraulic lithotripter probes and laser fibers may be used through either working channel.
The main component parts of each device include:
1. The metal shaft
2. Two working channels
3. An eyepiece
4. Optical imaging fibers
5. Light guide connector post
6. A distal lens
7. Light carrier fibers
This Special 510(k) proposes the addition of autoclaving processes as a sterilization method, a change in shaft material from stainless steel to MP35N alloy, as well as a change in the manufacturing process to allow the shaft to be hermetically sealed using a micro-TIG and laser welding process in place of epoxy seals. The indications for use, principles of operation, overall length, working channel length and working channel inner diameters of the ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes remain the same or essentially the same as the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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).
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
ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes ACMI Corporation Turnpike Road AUG 1 6 2005 uthborough, MA 01772
Special 510(k) Notification Summary of Safety and July 26, 2005
510(k) Summary of Safety and Effectiveness ACMI Corporation ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes
General Information
Manufacturer:
K052044
pg 1 of 2
ACMI Corporation 136 Turnpike Rd. Southborough, MA 01772-2104
Establishment Registration Number:
Contact Person:
Director, Regulatory Affairs
Endoscope and accessories
(21 CFR 876.1500), Class II Gastroenterology/Urology Panel
Endoscope and accessories
ACMI® MR-6A/MR-6LA Autoclavable
Terrence E. Sullivan
2020483
July 26, 2005
Date Prepared:
Device Description
Classification Name:
Trade Name:
Generic/Common Name:
Predicate Device
ACMI® MR-Series Ureteroscopes
Ureteroscopes
Intended Uses
The ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes (MR-6A) are intended for The examination/operation of the urinary tract, and using additional accessories, to the claimmation operation of the exapentic procedures. These devices are marketed as perform various diagnostic and mering, disinfecting and sterilization are included in reusable devices, member for creaming, excition 7.0, "Cleaning, Disinfection, and Sterilization".
1
Special 510(k) Notification Summary of Safety and Effectiveness July 26, 2005
Product Description
K052044
py r of 2
Like the predicate ACMI® MR-Series Ureteroscopes, the ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes are semi-rigid endoscopes with two working channels. Flexible accessories such as stone baskets, retrievers, forceps, electrohydraulic lithotripter probes and laser fibers may be used through either working channel.
The main component parts of each device include:
- The metal shaft 1.
-
- Two working channels
- An evepiece 3.
-
- Optical imaging fibers
- Light guide connector post 5.
- A distal lens 6.
-
- Light carrier fibers
This Special 510(k) proposes the addition of autoclaving processes as a sterilization method, a change in shaft material from stainless steel to MP35N alloy, as well as a change in the manufacturing process to allow the shaft to be hermetically sealed using a micro-TIG and laser welding process in place of epoxy seals. The indications for use, principles of operation, overall length, working channel length and working channel inner diameters of the ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes remain the same or essentially the same as the predicate device.
Summary of Safety and Effectiveness
The proposed modifications for the ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes, as described in this submission, are substantially equivalent to the predicate device. The proposed addition of autoclaving as a recommended sterilization process and change in shaft modification in design specifications, performance specifications, and dimensional specifications are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.
2
Image /page/2/Picture/2 description: The image shows a black and white logo. The logo features a stylized bird with three lines representing its wings or feathers. The bird is facing to the right. There is some text in a circular arrangement to the left of the bird, but the text is not legible.
AUG 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Terrence E. Sullivan Director, Regulatory Affairs ACMI Corporation 136 Turnpike Road SOUTHBOROUGH MA 01772
Re: K052044
Trade/Device Name: ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Dated: July 26, 2005 Received: July 28, 2005
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, 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 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 (OS) 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 Section 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:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
4
Device Name: ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes
510(k) Number: K 052044
Indications for use:
The ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes are intended for the examination/operation of the urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures.
(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)
. 1
Nancy C brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number