(60 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML algorithms or data processing.
No.
The device facilitates foreign body removal and endoscopic procedures by providing trans-oral access and preventing multiple insertions, but it does not directly treat a disease or medical condition.
No
The device is described as an "OverTube™ Endoscopic Access System" used for foreign body removal or endoscopic procedures requiring multiple insertions of an endoscope. Its description focuses on its physical components (shaft, hub, cuff seal) and its function as an access system, not on diagnosing conditions. The performance studies also focus on mechanical and material integrity rather than diagnostic accuracy.
No
The device description clearly outlines a physical device made of polymer and metal, with a hub, cuff seal, and specific dimensions. It also mentions sterilization and physical performance testing, 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 foreign body removal or endoscopic procedures within the gastrointestinal tract. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The description details a physical device used to facilitate endoscopic procedures. It does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
To be used in conjunction with an endoscope for foreign body removal or endoscopic procedures requiring multiple insertions of the endoscope into the lower or upper gastrointestinal tract.
Product codes (comma separated list FDA assigned to the subject device)
FED
Device Description
The OverTube™ Endoscopic Access System is comprised of a single, polymer extrusion shaft reinforced with a metallic coil. The hub located at the proximal end of the device contains a cuff seal which can be inflated with air using a syringe to reduce loss of pressure when insufflation is used. The device is available in a single effective length of 27 cm with a tapered distal tip. The OverTube™ Endoscopic Access System will be delivered in a manner that a clinician may open one (1) OverTube per clinical procedure. The OverTube™ Endoscopic Access System will be provided in both sterile and non-sterile models. The sterile model is terminally sterilized by ethylene oxide (EO).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower or upper gastrointestinal tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician
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)
Performance testing was conducted on the OverTube™ Endoscopic Access System to establish substantial equivalence. Functional performance testing included insertion and removal force requirements, shaft deflection, leakage rate, bond strength and foreign body removal. The OverTube™ Endoscopic Access System was subjected to biocompatibility evaluation in accordance with ISO 10993-1:2009. Additionally the OverTube™ Endoscopic Access System was adopted into the existing ethylene oxide sterilization cycle which was validated in accordance with ISO 11135-1:2007.
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
-1
Section 5. 510(k) Summary for OverTube™ Endoscopic Access System
Company:
Apollo Endosurgery, Inc. 7000 Bee Cave Road, Suite 350 Austin, TX, USA 78746
Contact Person:
Heather Crawford, RAC Director of Quality and Regulatory Email: heather.crawford@apolloendo.com Office phone: 512.328.9990 extension 244 Fax: 512.328.9994
- K040836: US Endoscopy Disposable Overtube
Date Prepared:
Device:
18 September 2012
Trade Name: Regulation Number: Regulation Description: Product Code: Classification Panel:
Device Classification:
OverTube™ Endoscopic Access System 21 CFR § 876.1500 Endoscope and accessories FED Gastroenterology/Urology Class II
Predicate Device(s):
Indications for Use:
Device Description:
To be used in conjunction with an endoscope for foreign body removal or endoscopic procedures requiring multiple insertions of the endoscope into the lower or upper gastrointestinal tract.
The OverTube™ Endoscopic Access System is comprised of a single, polymer extrusion shaft reinforced with a metallic coil. The hub located at the proximal end of the device contains a cuff seal which can be inflated with air using a syringe to reduce loss of pressure when insufflation is used. The device is available in a single effective length of 27 cm with a tapered distal tip. The OverTube™ Endoscopic Access System will be delivered in a manner that a clinician may open one (1) OverTube per clinical procedure. The OverTube™ Endoscopic Access System will be provided in both sterile and non-sterile models. The sterile model is terminally sterilized by ethylene oxide (EO).
1
K122270
-2
Technological Characteristics and Substantial Equivalence
The following table compares the OverTube™ Endoscopic Access System to the predicate device with respect to intended use and technological characteristics, providing more detailed information regarding the basis for the determination of substantial equivalence.
| Parameter | Apollo Endosurgery
OverTube™ Endoscopic
Access System | US Endoscopy
Disposable Overtube
(Guardus®) |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | To be assigned | K040836 |
| Indications for Use | To be used in conjunction with
an endoscope for foreign body
removal or endoscopic
procedures requiring multiple
insertions of the endoscope
into the lower or upper
gastrointestinal tract. | The disposable Overtube is a
device used in conjunction
with a flexible endoscope for
foreign body or tissue
retrieval and/or for
endoscopic procedures
requiring multiple endoscope
intubations. |
| Regulation Number | 876.1500 | 876.1500 |
| FDA Product Code | FED | KOG |
| Prescription / OTC Use | Prescription | Prescription |
| Single-Use / Reusable | Single-Use | Single-Use |
| Dimensions | | |
| Effective Length | 27 cm | 25 cm - 50 cm |
| Overtube Shaft OD | 19.5 mm | 19.5 mm |
| Overtube Shaft ID | 16.7 mm | 16.7 mm |
| Tapered Tip ID | 11 mm | 10.4 mm (insertion tube)
16.8 mm (outer tube) |
| Physical Characteristics | | |
| Overall Design | Single tube | Dual tube |
| Compatible Scope OD (mm) | 10 mm – 16 mm | 8.6 mm – 11.7 mm |
| Reinforcement Material | Wire coil design | Wire coil design |
| Tapered Tip | Yes | Yes |
| Insufflation Method | Cuff | Cap |
| Sterilization and Shelf Life | | |
| Sterility | Sterile and Non-sterile | Non-sterile only |
| Sterilization Method | Ethylene oxide | None |
| Primary Package | Pouch | Tray |
| Shelf Life (Use By Date) | Three (3) years | Three (3) years |
| Units per Shelf Box | Three (3) | Three (3) |
Table 5-1. Device Comparison Table
2
Summary of Non-Clinical Data Submitted
Performance testing was conducted on the OverTube™ Endoscopic Access System to establish substantial equivalence. Functional performance testing included insertion and removal force requirements, shaft deflection, leakage rate, bond strength and foreign body removal. The OverTube™ Endoscopic Access System was subjected to biocompatibility evaluation in accordance with ISO 10993-1:2009. Additionally the OverTube™ Endoscopic Access System was adopted into the existing ethylene oxide sterilization cycle which was validated in accordance with ISO 11135-1:2007.
Safety and Effectiveness
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics, and it can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.
It has been shown in this 510(k) submission that the differences between the OverTube™ Endoscopic Access System and predicate device do not raise any questions regarding its safety and effectiveness. The OverTube™ Endoscopic Access System, as designed and manufactured, therefore is determined to be substantially equivalent to the referenced predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP
2 8 2012
Ms. Heather Crawford. RAC Director, Quality and Regulatory Apollo Endosurgery, Inc. 7000 Bee Cave Road, Suite 350 AUSTIN TX 78746
Re: K12270
Trade/Device Name: OverTube™ Endoscopic Access System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED Dated: July 27, 2012 Received: July 30, 2012
Dear Ms. Crawford:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed four because or self people is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreations of the enactment date of the Medical Device Amendments, or to Conimeres phor to may 20, 1970, are excordance with the provisions of the Federal Food, Drug, de noos that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dicitions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability additionship. There new www. that device labeling must be truthful and not misleading.
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 It may be subject to additional controllar 2.1.2.2011 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 ore of the of the of Frease of advised that I DTT I risualled on on one complies with other requirements of the Act
that FDA has made a determination that your device complies with other requirem that I DA has made a dolorimisations administered by other Federal agencies. You must Of any I cocrai statuates and regulations, but not limited to: registration and listing Comply with an the Act 5 requirements, includes, includes reporting (reporting of medical
4
Page 2-
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de vice-iclated adverse evones) (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific advice for your do need on on 2 tables offices/ucm115809.htm for go to mup.mww.ida.gov/rroodd Drical Health's (CDRH's) Office of Compliance. Also, please, p the Center for DOTICOS and Realers of the Premarket notification" (21CFR Part note the regulations regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Tou may obtain other generational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin K. Fisher
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name:
OverTube™ Endoscopic Access System
Indications for Use:
To be used in conjunction with an endoscope for foreign body removal or endoscopic procedures requiring multiple insertions of the endoscope into the lower or upper gastrointestinal tract.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH/Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Gastro-Renal, and | |
| Urological Devices | |
| 510(k) Number | K122270 |
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