(89 days)
Not Found
No
The summary describes a mechanical device for aiding endoscopic procedures and does not mention any AI/ML components or functionalities.
No
The device aids in endoscopic procedures by facilitating the insertion, advancement, and removal of other endoscopic devices, rather than directly treating a disease or condition itself.
No
The provided text explicitly states that the device is "used to aid in the insertion, advancement, and removal of endoscopic devices during endoscopic procedures," and that it "is designed to work with upper gastrointestinal diagnostic endoscopes." This indicates its role is procedural assistance for other diagnostic tools, not diagnostic itself.
No
The device description clearly states it is an "external channel for an endoscope" and is a physical, single-patient use device attached to an endoscope. It also mentions biocompatibility and bench testing, which are typical for physical medical devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to aid in the insertion, advancement, and removal of endoscopic devices during endoscopic procedures. This describes a device used directly on or within the patient's body for a procedural purpose.
- Device Description: The description reinforces its use as an external channel attached to an endoscope for procedural assistance.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body. This device is a tool used during a medical procedure performed directly on the patient.
N/A
Intended Use / Indications for Use
The Sidecar External Working Channel is an external channel for an endoscope (8.6 to 12.8 mm in diameter) used to aid in the insertion, advancement, and removal of endoscopic devices during endoscopic procedures.
Product codes
FED
Device Description
The Sidecar External Working Channel is an external channel for an endoscope used for inserting, advancing, and removing endoscopic devices during endoscopic procedures. It is supplied non-sterile and is intended to be a single-patient use device. It is designed to work with upper gastrointestinal diagnostic endoscopes with an outer diameter from 8.6 mm . It is attached to the distal and proximal ends of an endoscope and inserted with the endoscope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospitals, sub-acute care institutions, surgery centers, or doctor's office where endoscopic procedures may be performed
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
Biocompatibility Testing: Biocompatibility testing was performed in accordance with the FDA Blue Book Memorandum #G95-1 Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing and ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process.
Bench Testing: Design verification and validation testing were performed on the Sidecar External Working Channel to evaluate physical, simulated use, reliability, and safety specifications.
Key Results: The design verification test results demonstrate that the Sidecar External Working Channel should perform as intended in the specified use conditions and should perform comparably to the legally marketed predicate that is currently marketed for the same intended use.
Key Metrics
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing right, with a symbol resembling a caduceus above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2015
C2 Therapeutics, Inc. Theresa Brandner-Allen VP of Regulatory Affairs and Quality Assurance 303 Convention Way, Suite 1 Redwood City, CA 94063
Re: K150083
Trade/Device Name: Sidecar External Working Channel Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED Dated: March 13, 2015 Received: March 16, 2015
Dear Theresa Brandner-Allen,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, 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 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions 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 Division of Industry and Consumer Education 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,
Herbert P. Lerner -S
for 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
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Indications for Use
510(k) Number (if known) K150083
Device Name Sidecar External Working Channel
Indications for Use (Describe)
The Sidecar External Working Channel is an external channel for an endoscope (8.6 to 12.8 mm in diameter) used to aid in the insertion, advancement, and removal of endoscopic devices during endoscopic procedures.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☒ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
I. SUBMITTER
C2 Therapeutics, Inc. 303 Convention Way, Suite 1 Redwood City, CA 94063 Phone: 650-521-5921 Fax: 650-556-1145
| Contact Person: | Theresa Brandner-Allen |
|---|---|
| VP of Regulatory Affairs and Quality Assurance | |
| Date Prepared: | January 12, 2015 |
II. DEVICE
Name of Device: Sidecar External Working Channel, endoscopic access overtube Common Name: Endoscopic access overtube, gastroenterology-urology Classification Name: Endoscopic access overtube, gastroenterology-urology 21 CFR§876.1500
Regulatory Class: Class II Product Code: FED
III. PREDICATE DEVICE
EndoFLIP External Channel Device (EF-800), K110531 This predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The Sidecar External Working Channel is an external channel for an endoscope used for inserting, advancing, and removing endoscopic devices during endoscopic procedures. It is supplied non-sterile and is intended to be a single-patient use device. It is designed to work with upper gastrointestinal diagnostic endoscopes with an outer diameter from 8.6 mm . It is attached to the distal and proximal ends of an endoscope and inserted with the endoscope.
V. INDICATIONS FOR USE
The Sidecar External Working Channel is an external channel for an endoscope (8.6 to 12.8 mm in diameter) used to aid in the insertion, advancement, and removal of endoscopic devices during endoscopic procedures.
| Patient Population: | Patients undergoing endoscopic procedures |
|---|---|
| Environment of Use: | Hospitals, sub-acute care institutions, surgery centers, or |
| doctor's office where endoscopic procedures may be performed | |
| Contraindications: | The Sidecar External Working Channel is contraindicated |
| where endoscopy is contraindicated |
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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Sidecar External Working Channel has similar technological characteristics to the legally marketed predicate. The subject device and predicate device are based on the following same technological elements:
- Attached over an endoscopic device to provide an external working channel ●
- Aids in the insertion, advancement, and removal of the endoscopic accessories during ● endoscopic procedures
- . Used in hospitals, sub-acute care institutions, surgery centers, or doctor's office where endoscopic procedures may be performed
- Used for patients undergoing endoscopic procedures .
The following technological differences exist between the subject device and predicate device:
- . Attachment and removal from the endoscope does not require use of a tool
- Compatible with a wider range of endoscope diameters ●
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
Biocompatibility testing was performed in accordance with the FDA Blue Book Memorandum #G95-1 Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing and ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process.
Bench Testing
Design verification and validation testing were performed on the Sidecar External Working Channel to evaluate physical, simulated use, reliability, and safety specifications.
VIII. CONCLUSION
The Sidecar External Working Channel has the same clinical attributes, technological characteristics, and expected performance as the legally marketed predicate, EndoFLIP External Channel Device (K110531). The design verification test results demonstrate that the Sidecar External Working Channel should perform as intended in the specified use conditions and should perform comparably to the legally marketed predicate that is currently marketed for the same intended use.