(55 days)
Not Found
No
The device description focuses on mechanical components and manual manipulation for deflection, with no mention of AI or ML for control, analysis, or assistance.
No
The device is designed to assist in the placement and deflection of catheters and endoscopes, helping to direct other instruments to a specific surgical site. It facilitates therapeutic procedures but is not itself performing a therapeutic action.
No
This device is designed to assist in the placement and deflection of catheters and endoscopes for surgical procedures, acting as a navigational aid rather than providing diagnostic information itself.
No
The device description clearly outlines physical components like tubes, wires, and a handle, indicating it is a hardware device, not software-only.
Based on the provided information, the OmniSonics Endoscopic Deflector is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- OmniSonics Endoscopic Deflector Function: The description clearly states that this device is used to assist in the placement and deflection of catheters and endoscopes within the body during surgical procedures. It is a tool for manipulating other instruments inside the body, not for analyzing samples taken from the body.
- Intended Use: The intended use describes its application in various surgical procedures within body cavities, hollow organs, and canals. This is an in vivo (within the living body) application, not in vitro (in glass, or outside the body).
- Device Description: The description details its mechanical components and how it physically deflects instruments inside the body. There is no mention of analyzing biological samples.
Therefore, the OmniSonics Endoscopic Deflector is a surgical instrument used in vivo, not an IVD device.
N/A
Intended Use / Indications for Use
The OmniSonics Endoscopic Deflector is designed to assist in the placement and deflection of I he Onlinoomiss indoscopic Donector atheters and endoscopes used in surgical procedures in body cavities, hollow organs and canals.
The OmniSonics Endoscopic Deflector is designed to be introduced through natural body openings, surgical incisions and through introducers, needles, trocars, catheters, sheaths and other devices with lumens having an inside diameter larger than the outside diameter of the OmniSonics Endoscopic Deflector shaft selected. The OmniSonics Endoscopic Deflector is sold sterile and is intended for single patient use. The OmniSonics Endoscopic Deflector is indicated for the following applications:
Ureteroscopy Thoracoscopy Nasopharyngoscopy Sinuscopy General laparoscopy Urology Gynecology Bronchoscopy
Product codes
GCM
Device Description
The OmniSonics Endoscopic Deflector assists in the delivery of small diameter flexible; instruments, catheters, probes, and endoscopes. The device deflects these instruments to aid in the direction and delivery of the product to a specific surgical site that is not in line with the axis of the instrument. The purpose of the OmniSonics Endoscopic Deflector is to provide a means to deliver small diameter instruments to areas that would be difficult to access with a straight instrument.
The OmniSonics Endoscopic Deflector works in a similar fashion to steerable endoscopes. This instrument is different in that it only contains lumens for the introduction of ancillary instrumentation and does not possess an integral visualization system. The user must insert all of the additional capabilities desired through the OmniSonics Endoscopic Deflector central lumen.
Products that are capable of working with the OmniSonics Endoscopic Deflector are flexible, malleable or bendable and must be capable of obtaining a bend radius of 30 mm or less. They must also have an outer diameter compatible with the inner diameter of the unit selected. The actual deflection produced at the end of the device will depend upon the stiffiess of the inserted instrument.
Device Configuration and Materials
The OmniSonics Deflector is constructed with the following major components:
Outer sheath tube: A rigid, stainless steel tube that provides rigidity for insertion into the body
Deflection tube: A flexible, polyurethane, kink resistant tube that bends when the deflection handle is activated.
Deflection wire: A stainless steel wire that pulls the tip of the deflection tube to cause deflection.
Deflection handle: An ABS handle that has mechanisms for rotation of the shaft, articulation of the deflection tube, movement of the inserted device in and out and sealing of the inserted device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body cavities, hollow organs, and canals.
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)
Performance Testing
The OmniSonics Deflector conforms to IEC 60601-18
All materials used are biocompatable
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines, creating a sense of unity and movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
OmniSonics Medical Technologies, Inc. Ms. Debbie Iampietro QRC Consulting 7 Tiffany Trail Hopkinton, MA 01748
JUL 2 7 2015
K993445 Re:
Trade/Device Name: Endoscopic Deflector Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCM Dated (Date on orig SE Itr): October 8, 1999 Received (Date on orig SE ltr): October 12, 1999
Dear Ms. Iampietro,
This letter corrects our substantially equivalent letter of December 6, 1999.
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
1
Page 2 -
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers. International 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International 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 R. Fisher -S
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
2
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: OmniSoncis Endoscopic Deflector
Indications For Use:
The OmniSonics Endoscopic Deflector is designed to assist in the placement and deflection of I he Onlinoomiss indoscopic Donector atheters and endoscopes used in surgical procedures in body cavities, hollow organs and canals.
The OmniSonics Endoscopic Deflector is designed to be introduced through natural body openings, surgical incisions and through introducers, needles, trocars, catheters, sheaths and other devices with lumens having an inside diameter larger than the outside diameter of the OmniSonics Endoscopic Deflector shaft selected. The OmniSonics Endoscopic Deflector is sold sterile and is intended for single patient use. The OmniSonics Endoscopic Deflector is indicated for the following applications:
Ureteroscopy Thoracoscopy Nasopharyngoscopy Sinuscopy General laparoscopy Urology Gynecology Bronchoscopy
(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 General Restorative Devices | |
| 510(k) Number | K993445 |
3
OmniSonics Medical Technologies, Inc
Robert A Rabiner President
DEC - 6 1999
510K Summary OmniSonics Endoscopic Deflector
1. Sponsor Name
OmniSonics Medical Technologies 14 Equestrian Drive North Reading, MA 01864
Telephone: (978) 664 8440 Contact Individual: Debbie Iampietro
2. Device Name
Proprietary Name: OmniSonics Endoscopic Deflector Common/Usual Name: Endoscope Classification Name: Endoscope and accessories
3. Identification of Predicate or Legally Marketed Device
The OmniSonics Endoscopic Deflector is substantially equivalent to several legally marketed devices in intended use, design and technological characteristics. Those devices to which it is substantially equivalent are: Omnisonics Endoscopes (K991377), Karl Storz Hystero-Fiberscope (K990411), Karl Storz Laser Application Instrument (K# unknown), and the Naviport Deflectable Tip Guiding Catheter (K974683).
4. Device Description
Principle of Operation
The OmniSonics Endoscopic Deflector assists in the delivery of small diameter flexible; instruments, catheters, probes, and endoscopes. The device deflects these instruments to aid in the direction and delivery of the product to a specific surgical site that is not in line with the axis of the instrument. The purpose of the OmniSonics Endoscopic Deflector is to provide a means to deliver small diameter instruments to areas that would be difficult to access with a straight instrument.
14 Equestrian Drive North Reading, MA 01864 978 664 8440 978 664 4248 rrabiner@worldnet.att.net
001059
4
OmniSonics Medical Technologies, Inc
Robert A Rabiner President
The OmniSonics Endoscopic Deflector works in a similar fashion to steerable endoscopes. This instrument is different in that it only contains lumens for the introduction of ancillary instrumentation and does not possess an integral visualization system. The user must insert all of the additional capabilities desired through the OmniSonics Endoscopic Deflector central lumen.
Products that are capable of working with the OmniSonics Endoscopic Deflector are flexible, malleable or bendable and must be capable of obtaining a bend radius of 30 mm
or less. They must also have an outer diameter compatible with the inner diameter of the unit selected. The actual deflection produced at the end of the device will depend upon the stiffiess of the inserted instrument.
Device Configuration and Materials
The OmniSonics Deflector is constructed with the following major components:
| Outer sheath tube: | A rigid, stainless steel tube that provides rigidity for insertion into the body |
|---|---|
| Deflection tube: | A flexible, polyurethane, kink resistant tube that bends when the deflection handle is activated. |
| Deflection wire: | A stainless steel wire that pulls the tip of the deflection tube to cause deflection. |
| Deflection handle: | An ABS handle that has mechanisms for rotation of the shaft, articulation of the deflection tube, movement of the inserted device in and out and sealing of the inserted device. |
ર. Intended Use
Intended use
The OmniSonics Endoscopic Deflector is a device designed to assist in the placement and deflection of small diameter malleable instruments, catheters and endoscopes used in surgical procedures in body cavities, hollow organs and canals.
The OmniSonics Endoscopic Deflector is designed to be introduced through natural body openings, surgical incisions and through introducers, needles, trocars, catheters, sheaths and other devices with lumens having an inside diameter larger than the outside diameter of the OmniSonics Endoscopic Deflector shaft selected. The OmniSonics Endoscopic Deflector is sold sterile and is intended for single patient use. The OmniSonics Endoscopic Deflector is indicated for the following applications:
14 Equestrian Drive North Reading, MA 01864 978 664 8440 978 664 4248 rrabiner@worldnet.att.net
000060
5
OmniSonics Medical Technologies, Inc
Robert A Rabiner President
Ureteroscopy Thoracoscopy Nasopharyngoscopy Sinuscopy General laparoscopy Urology Gynecology Bronchoscopy
Comparison of Technological Characteristics ર.
All of the predicate devices are similar in intended use, design and materials. The proposed An of the president devices are smilamate materials that have been widely used in other endoscopic applications and have a long history of use.
All of the predicate devices offer various configurations, lengths, diameters, and have An of the production. The proposed OmniSonics Endoscopic Deflector's varying degress or deflection. The propes established by the predicate devices and similar to other devices in the medical device industry.
The technological characteristics used in the proposed OmniSonics Endoscopic Deflector to assist in the placement, deflection and/or articulation of medical devices into body cavities, hollow organs and canals are inherent in the predicate Karl Storz Laser Application Instrument and the Naviport Deflectable Tip Guiding Catheter.
The difference in technological characteristics is in the generic application of the The university in womanological cor. Each of the predicates and devices cited for similarities in deflection capability are "dedicated" to the devices they accompany. The OmniSonics Endoscopic Deflector is not dedicated to one instrument or corporate family of instruments. It is to be used with other devices that are compatible to its design characteristics as identified in its labeling.
Since the OmniSonics Endoscopic Deflector is the same in intended use, design, principle of operation, technological characteristics, and materials as the predicate devices, the Openiatore Endoscopic Deflector does not raise any new safety and efficacy concerns when compared to these similar legally marketed devices. Therefore, the OmniSonics Endoscopic Deflector is substantially equivalent to these existing devices.
- 7
Performance Testing The OmniSonics Deflector conforms to IEC 60601-18 All materials used are biocompatable
14 Equestrian Drive North Reading, MA 01864 978 664 8440 978 664 4248 rrabiner@worldnet.att.net
. "A
000061