(186 days)
K93006
K93006
No
The summary describes a mechanical device (balloon elevator) used in conjunction with an endoscope retractor. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
No
The device, a balloon elevator, is used to provide support for a retractor and gently spread tissue during endoscopic surgery; it does not directly treat a disease or condition.
No
The device is described as a surgical tool designed to spread tissue and support a retractor during endoscopic surgery, not to diagnose a condition.
No
The device description clearly indicates a physical device ("Balloon Elevator") designed to fit on an endoscope retractor and inflate, which are hardware functions.
Based on the provided information, the Scion Balloon Elevator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device used during surgical procedures (endoscopic surgery) to manipulate tissue and provide support. This is an in vivo application, meaning it's used within a living organism.
- IVD Definition: In vitro diagnostics are devices used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health. The Scion Balloon Elevator does not perform this function.
The description focuses on mechanical manipulation of tissue during surgery, which is characteristic of a surgical instrument, not an IVD.
N/A
Intended Use / Indications for Use
The Scion Balloon Elevator is designed for endoscoopic surgery involved in extraperitoneal or subcutaneous spaces in such common procedures as Saphenous Vein Harvest. The Balloon elevator is designed to fit on the end of our Endoscope Retractor (510K #93006) and atraumatically provide support for the distal end of the retractor. The other function of the balloon is to gently spread tissue by the inflation of the balloon.
Product codes
GCJ
Device Description
The Scion Balloon Elevator is designed for endoscoopic surgery involved in extraperitoneal or subcutaneous spaces in such common procedures as Saphenous Vein Harvest. The Balloon elevator is designed to fit on the end of our Endoscope Retractor (510K #93006) and atraumatically provide support for the distal end of the retractor. The other function of the balloon is to gently spread tissue by the inflation of the balloon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Extraperitoneal or subcutaneous spaces (e.g. for Saphenous Vein Harvest)
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)
K93006
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure with three tail feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 1998
Mr. Stephen Chakoff President Scion International, Incorporated 5200 Blue Lagoon Drive, Suite 890 Miami, Florida 33126
Re: K973698 Trade Name: Scion Balloon Elevator Regulatory Class: II Product Code: GCJ December 29, 1997 Dated: December 31, 1997 Received:
Dear Mr. Chakoff:
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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include reguirements 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission 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 requlations.
1
Page 2 - Mr. Chakoff
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 Compliance at (301) 594-4595. 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/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
2
Page 1of 1
510(k) Number (if known):
SCION Balloon Elevator Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Scion Balloon Elevator is designed for endoscoopic surgery involved in extraperitoneal or subcutaneous spaces in such common procedures as Saphenous Vein Harvest. The Balloon elevator is designed to fit on the end of our Endoscope Retractor (510K #93006) and atraumatically provide support for the distal end of the retractor. The other function of the balloon is to gently spread tissue by the inflation of the balloon.
(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 General Restorative Devices
| 510(k) Number | K973690 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| --------------------------------------- | --- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Optional Format 1-2-96)