(43 days)
Not Found
No
The 510(k) summary describes a mechanical overtube and does not mention any AI/ML components or image processing.
No.
The device description indicates it is an overtube designed to aid in endoscopic insertion and advancement, which are procedural aids rather than direct therapeutic actions on a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" states the device is "to aid in endoscopic insertion and advancement during diagnostic and therapeutic lower GI flexible endoscopy," directly indicating its use in diagnostic procedures.
No
The device description explicitly states it is a "flexible overtube," which is a physical, hardware component. The performance studies also describe testing of physical parts ("helix and collars").
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used with a flexible endoscope to aid in insertion and advancement during endoscopic procedures. This is a mechanical aid for a medical procedure performed in vivo (within the body).
- Device Description: The description confirms it's a flexible overtube designed for use with endoscopes in the lower GI tract. This is a physical device used during a procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with specimens or analysis of biological samples.
- Performance Studies: The performance studies mentioned are related to the physical properties of the device (tensile testing), not diagnostic performance metrics like sensitivity or specificity which are common for IVDs.
Therefore, the Spirus Medical, Inc. Endo-Ease Endoscopic Overtube is a medical device used during an endoscopic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Spirus Medical, Inc. Endo-Ease Endoscopic Overtube is indicated for use with a flexible endoscope to aid in endoscopic insertion and advancement during diagnostic and therapeutic lower GI flexible endoscopy.
Product codes
KOG
Device Description
The device described in this 510(k) consists of a sterile, single use, flexible overtube designed for use with currently marketed flexible endoscopes in the lower & I tract.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower GI
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)
Substantial equivalence for the new device was based on design characteristics, comparison to legally marketed predicate devices, and performance testing. Performances tosting consisted of destructive tensile testing of the helix and collars.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Spirus Medical, Inc. July 29, 2005
SEP 1 4 2005
510(k) Premarket Notific Endo-Ease Endosconic Overt
510(k) Summary
| Trade Name: | Endo-Ease™ |
|---|---|
| Sponsor: | Spirus Medical, Inc. |
| 1063 Turnpike Street | |
| Stoughton, MA 02072 | |
| FDA Registration No. not yet assigned | |
| Device Common | |
| Name: | Endoscopic overtube |
| Classification: | According to Section 513 of the Federal Food, Drug, and |
| Cosmetic Act, the device classification is Class II. | |
| Predicate Devices: | K040048 - Balloon Overtube (Fujinon Corp.) |
| K973500 - Bard Endoscopic Overtube (C.R. Bard, Inc.) | |
| K040836 - Disposable Overtube (U.S. Endoscopy) |
Product Description:
The device described in this 510(k) consists of a sterile, single use, flexible overtube designed for use with currently marketed flexible endoscopes in the lower & I tract.
Indications for Use:
The Spirus Medical, Inc. Endo-Ease Endoscopic Overtube is indicated for use with a flexible endoscope to aid in endoscopic insertion and advancement during diagnostic and therapeutic lower GI flexible endoscopy.
Safety and Performance:
Substantial equivalence for the new device was based on design characteristics, comparison to legally marketed predicate devices, and performance testing. Performances tosting consisted of destructive tensile testing of the helix and collars.
Conclusion:
Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the proposed Spirus Medical, Inc. Endo-Ease Endoscopic Overtube has been shown to be safe and effective for its intended use.
1
Image /page/1/Picture/2 description: The image shows a logo with a stylized bird in flight. The bird is depicted with simple, curved lines, giving it a minimalist and modern appearance. To the left of the bird, there is a circular arrangement of text, which appears to be a name or title associated with the logo. The overall design is clean and professional, suggesting a company or organization focused on innovation or movement.
SEP 1 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MO 20850
Spirus Medical, Inc. c/o Ms. Pamela Papineau, RAC Consultant Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue AYER MA 01432
Re: K052084 K052001
Trade/Device Name: Endo-Ease Endoscopic Overtube Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: KOG Dated: July 29, 2005 Received: August 2, 2005
Dear Ms. Papineau:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced We have reviewed your Section Frons) promation in accurations for the indications for use stated in above and nave delenimical the devices marketed in interstate commerce prior to devices that be the enclosure) to regally marketed prodicals correst and included May 28, 1976, the ellaculient use of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordance with the provisions of and included (PMA). You may, therefore, market the do not require approval of a provisions of the Act. The general controls provisions of the Act
device, subject to the general controls provisions of the Act. The general con device, subject to the general controls 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 If your device is classified (see above) into only of the Regulations affecting your Approval), it may be subject to such additions, Title 21, Pars 800 to 898. In addition, FDA
device can be found in the Code of Federal Regulations, Title 21, Paris 800 to 80 device can be found in the Code of Fouchar Registering your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA S Issualice of a subscribed other requirements of the Act or ally
FDA has made a determination that your device with other requirements with all FDA has made a delemination mar your de 160 compress. You must comply with all the Federal statutes and regulations administered of out it toon and listing (21 CFR Part 807); labeling Act's requirements, including, but not interests requirements set for in the quality systems (QS)
(21 CFR Part 801); good manufacturing practice requirements matted provision (21 CFR Part 801); good manufacturing proctices toopically product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
2
This letter will allow you to begin marketing your device as described in your Section 510(k)
Children and the many of a finding of pubclence of your device to a legal This letter will allow you to begin marketing your device of your device of your device of your device to a legally
premarket notification. The FDA finding if substantial eq premarket notification. The FDA inding of substantial equivalence of your device of your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r and the success of the county of the fillering numbers, based on the re If you desire specific advice for your device on our labeling regulation (even 1977).
contact the Office of Compliance at one of the following numbers, based on the regulatio 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 entiled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Misoralianing of responsibilities under the Act from the Act from the 807.97). You may obtain other general intornalion on your respections of its toll-free number (800)
Division of Small Manufacturers, International Inc. DIVIsion of Small March 2017 or at its Internet address 050-2041 or (5010/04/2drh/industry/support/index.html
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Spirus Medical, Inc. July 29, 2005
510(k) Premarket Notification: T Endo-Ease Endoscopic Overtube
Page
510(k) Number (if known): K052084
Device Name:
.
1984 - 1
Endo-Ease Endoscopic Overtube
Indications for Use:
The Spirus Medical, Inc. Endo-Ease Endoscopic Overtube is indicated for use with a The Spirus Medical, Inc. Endo Easo Endoscopic insertion and advancement during diagnostic and therapeutic lower GI flexible endoscopy.
(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 __
Nancyc brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. R052084