(63 days)
Not Found
Not Found
No
The device description focuses on the physical characteristics and intended use of a non-powered, disposable speculum, with no mention of software, image processing, or AI/ML capabilities.
Yes
The device is intended for "certain treatment procedures involving the anal-rectal anatomy," indicating it is used for therapeutic purposes.
Yes
The device is described as enabling "visual examination" and having an "operative port enabling precise isolation of tissue and pathology," which indicates its use in identifying or confirming medical conditions.
No
The device description explicitly details a physical speculum constructed of resin with an obturator and handle, indicating it is a hardware device, not software-only.
Based on the provided information, the Dispos-A-Scope is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "visual examination and certain treatment procedures involving the anal-rectal anatomy." This involves direct interaction with the patient's body for observation and treatment, not for testing samples in vitro (outside the body).
- Device Description: The description details a physical instrument used for examination and procedures within the body. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Reagents or assays
- Analysis of biological samples (blood, urine, tissue, etc.)
- Measurement of biomarkers or other biological indicators
- Diagnostic testing performed on samples outside the body
Therefore, the Dispos-A-Scope is a medical device used for direct examination and treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Dispos-A-Scope is intended for physician use enabling visual examination and certain treatment procedures involving the anal-rectal anatomy.
Product codes (comma separated list FDA assigned to the subject device)
78 FER
Device Description
The Dispos-A-Scope is intended for physician use enabling visual examination and certain treatment procedures involving the anal-rectal anatomy. The Dispos-A-Scope has 11cm speculum length enabling visualization of the ano-rectal canal. The Dispos-A-Scope is constructed totally of a quasi-transparent resin. The resin has passed USP Class VI testing. The scope is designed for one time use and then disposal eliminating the risk of cross infection and nullifying the need for sterilization of the instrument. The Dispos-A-Scope is non-powered. It does not conduct electricity and is non-thermogenic. The Dispos-A-Scope resin is quasi-compliant to external forces and will not crack or craze during normal usage. The Dispos-A-Scope has an operative port enabling precise isolation of tissue and pathology. The Dispos-A-Scope has a replaceable obturator facilitating device insertion and rotation for precise operative port placement during examination and treatment procedures. The Dispos-A-Scope has an ergonomic handle facilitating accurate physician manipulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anal-rectal anatomy, ano-rectal canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician use
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.
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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
11 943238
510(k) Summary
Device Name: Dispos-A-Scope
- The Dispos-A-Scope is intended for physician use enabling visual examination and certain treatment procedures involving the anal-rectal anatomy.
- . The Dispos-A-Scope has 11cm speculum length enabling visualization of the ano-rectal canal.
- The Dispos-A-Scope is constructed totally of a quasi-transparent resin. The . resin has passed USP Class VI testing. The scope is designed for one time use and then disposal eliminating the risk of cross infection and nullifying the need for sterilization of the instrument.
- The Dispos-A-Scope is non-powered. It does not conduct electricity and is ● non-thermogenic.
- The Dispos-A-Scope resin is quasi-compliant to external forces and will not crack . or craze during normal usage.
- . The Dispos-A-Scope has an operative port enabling precise isolation of tissue and pathology.
- The Dispos-A-Scope has a replaceable obturator facilitating device insertion and rotation for precise operative port placement during examination and treatment procedures.
- The Dispos-A-Scope has an ergonomic handle facilitating accurate physician manipulation.
1
Image /page/1/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 an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 6 2000
Laurel Nicholas, R.N. Owner Dispos-a-Scope Company 315 Skyline Drive Lewiston ID 83501
Re: K993738 Dispos-a-Scope Dated: October 27, 1999 Received: November 4, 1999 Regulatory Class II 21 CFR §876.1500/Procode: 78 FER
Dear Ms. Nicholas:
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 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, 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 requirements, 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 regult 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 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.
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 Compiance at (301) 594-4613. 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number: Pending
510(k) Number: Pending K993738 Pg 1 of r
Device Name: Dispos-A-Scope
Indications For Use:
- The Dispos-A-Scope is intended for physician use enabling visual examination and . certain treatment procedures involving the anal-rectal anatomy.
- The Dispos-A-Scope is 11cm long enabling visualization of the ano-rectal canal. .
- The Dispos-A-Scope is constructed totally of a quasi-transparent resin. The . resin has passed USP Class VI testing. The scope is designed for one time use and then disposal eliminating the risk of cross infection and nullifying the need for sterilization of the instrument.
- The Dispos-A-Scope is non-powered. It does not conduct electricity and is . non-thermogenic.
( Continued on Page 2)
(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) | OR | Over-The-Counter Use |
|---|---|---|
| --------------------------------------------------- | ---- | ---------------------- |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K993738 |
|---|---|
| --------------- | --------- |
3
$\qquad K \qquad 993738pg^{2}ofr$
- The Dispos-A-Scope resin is quasi-compliant to external forces and will not crack . or craze during normal usage.
- The Dispos-A-Scope has an ergonomic handle facilitating accurate physician . manipulation.
- The Dispos-A-Scope has an operative port enabling precise isolation of tissue and . pathology.
- The Dispos-A-Scope has a replaceable obturator facilitating device insertion and . rotation for precise operative port placement during examination and treatment procedures.
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 993738 510(k) Number.