(90 days)
Not Found
No
The device description focuses on mechanical dilation and access, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is described as an access port for diagnostic, therapeutic, and operative procedures, but it does not perform any therapy itself. Its function is to create a working channel for other instruments, including therapeutic ones.
No
Explanation: The device is described as creating a port of entry for diagnostic, therapeutic, and operative procedures, and for the passage of diagnostic instruments, but it does not perform diagnostic functions itself.
No
The device description clearly details physical components like an expandable dilator sheath assembly, tubular members, cannulas, and mentions assembly from medical grade materials, molding, machining, adhesives, welds, and mechanical interlocks. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the InnerDyne, Inc., G-RED® device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as providing dilation access for the performance of laparoscopic procedures to establish a port of entry for diagnostic, therapeutic, and operative procedures. This involves direct interaction with the patient's body for surgical and diagnostic access, not the examination of specimens in vitro (outside the body).
- Device Description: The description details a mechanical device used for creating and maintaining a passage through tissue. It focuses on the physical mechanism of dilation and providing a working channel for instruments. This aligns with a surgical access device, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to examine biological specimens (blood, urine, tissue, etc.) to provide information about a physiological state, health, or disease. The device's function is purely mechanical and procedural.
Therefore, the G-RED® device is a surgical access device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The InnerDyne, Inc., G-RED® device is intended to provide dilation access for the performance of laparoscopic procedures to establish a port of entry for diagnostic, therapeutic, and operative procedures.
- Percutaneous urological access, for typical procedures such as:
- Percutaneous nephroscopy
- Percutaneous bladder access (suprapubic)
- Percutaneous laparoscopic access to primary body cavities (i.e., abdominal and thoracic), both primary and secondary punctures; and
- Percutaneous access into hollow body organs.
The subject G-RED® device is intended for use during minimally invasive surgery for temporary dilation access to the abdominal and thoracic cavities for passage of diagnostic, therapeutic and operative instruments into the abdominal and thoracic cavities, and for percutaneous access to hollow body organs. The device is configured to be used as either a primary or secondary stick.
Product codes
GCJ
Device Description
The G-RED® device consists of an expandable dilator sheath assembly deployable via standard access (e.g., percutaneous trocar needle or catheter) / guidewire (Seldinger or similar) placement technique. The tubular member of the dilator is configured so as to be axially compressed to reduce the outside diameter of the expandable sheath, penetrating the tissue into the target cavity (e.g., abdominal) or hollow organ. Upon use, the dilator assembly reduces the outside diameter of the expandable sheath, penetrating the tissue into the target cavity (e.g., abdominal) or hollow organ.
For laparoscopic access to target cavities and hollow organs, the following instructions should be observed. After insufflation of the cavity, (if deemed necessary), the access needle is removed. The obturator is then inserted through the lumen of the dilator sheath which expands radially to accommodate it. This process in turn, radially expands the walls of the surrounding tissue. The obturator is removed, leaving the expanding dilation sheath and dilator, allowing access. This technique allows the user to benefit from the unique safety features and controllability of radial dilation by going from a less traumatic initial stick, followed by radial dilation to the desired working channel. Once the working channel is established, the expandable working cannula remains in place to provide a sealed port for passage of diagnostic, therapeutic, and/or surgical instruments at the discretion of the physician and at the convenience of the patient.
This system configuration allows the user to initially place a small diameter dilator cannula for passage of small diagnostic instruments. The dilator cannula can then be removed from the lumen of the dilator sheath while leaving the sheath inserted through the tissues. A larger diameter dilation cannula can then be inserted through the dilator sheath to create a larger port for passage of the larger operative instruments.
The device is assembled from medical grade materials under GMP conditions. Components are molded and machined by qualified suppliers. The components are assembled and secured by adhesives, welds, and mechanical interlocks. The G-RED® device is available in various lengths and working diameters to accommodate the selected size of indicated medical instruments. The subject product may be supplied in both disposable forms.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal and thoracic cavities, hollow body organs, urological (nephroscopy, bladder access)
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)
InnerDyne, Inc., G-RED® InnerDyne, Inc., Step® device versions, InnerDyne, Inc., R.E.D. ® device versions
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
990493
SUMMARY OF SAFETY & EFFECTIVENESS INFORMATION
-
InnerDyne, Inc. Submitter: 5060 West Amelia Earhart Drive Salt Lake City, Utah 84116 (801) 350-3600
Date Prepared: 22 January 1999 -
Rick Gaykowski Contact: Corporate Vice President, Regulatory Affairs and Quality Assurance
Classification Name: Dilator (Other) Glussmouthori Name: Percutaneous Dilator w/ Removable Sheath InnerDyne , Generic Radially Expanding Dilation "G-RED® " Trade/Proprietary Name: Device
The G-RED® device consists of an expandable dilator sheath assembly deployable via standard The O-Tice of needle or cather/guidewire (Seldinger or similar) placement technique. access (vercas typor noddio of outhers) is configured so as to be axially compressed to The tubular momber of the diserestion. Upon use, the dilator assembly reduce the outside than of the mandable sheath, penetrating the tissue into the target cavity (e.g., abdominal) or hollow organ.
For laparoscopic access to target cavities and hollow organs, the following instructions should I of loparoove After insufflation of the cavity, (if deemed necessary), the access needle is De differ the mountanda assembly, which consists of a blunt obturator and dilation removed. The unator our the lumen of the dilator sheath which expands radially to accommodate it. This process in turn, radially expands the walls of the surrounding tissue. accommodule in "This prirator is removed, leaving the expanding dilation sheath and dilator ronowing anation this cechnique allows the user to benefit from the unique safety features and controllability of radial dilation by going from a less traumatic initial stick, followed by radial controllability of facilities ) annel. Once the working channel is established, the diration to the dosire working onament of the patient, at the discretion of the expandable should the working cannula in place to provide a sealed port for passage of diagnostic, therapeutic, and/or surgical instruments.
This system configuration allows the user to initially place a small diameter dilator cannula for passage of small diagnostic instruments. The dilator cannula can then be removed from the lumen of the dilator sheath while leaving the sheath inserted through the tissues. A larger diameter dilation cannula can then be inserted through the dilator sheath to create a larger port for passage of the larger operative instruments.
30
1
The device is assembled from medical grade materials under GMP conditions. Components are molded and machined by qualified suppliers. The components are assembled and secured by adhesives, welds, and mechanical interlocks. The G-RED® device is available in various lengths and working diameters to accommodate the selected size of indicated medical instruments. The subject product may be supplied in both disposable forms.
device is substantially equivalent to the predicate The subject InnerDyne, Inc., G-RED® InnerDyne, Inc., Step® device versions in basic design, product configuration, composition, utilized materials, function, deployment, warnings and precautions, contraindications, and intended use for access to abdominal/thoracic cavities, the InnerDyne, Inc., R.E.D. ® device versions for access to hollow body organs, and equivalent to a number of currently marketed products with the removable sheath design.
The subject G-RED® device is intended for use during minimally invasive surgery for temporary dilation access to the abdominal and thoracic cavities for passage of diagnostic, therapeutic and operative instruments into the abdominal and thoracic cavities, and for percutaneous access to hollow body organs. The device is configured to be used as either a primary or secondary stick.
From the foregoing, we conclude that the subject G-RED® device is as safe and effective as named predicates and currently marketed competitive devices for the stated indications.
31
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the department's logo in the center. The logo is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 18
Mr. Rick Gaykowski Corporate Vice President, Regulatory Affairs and Quality Assurance InnerDyne, Inc. 5060 West Amelia Earhart Drive Salt Lake City, Utah 84116
K990493 Re:
Trade Name: InnerDyne, Inc., Generic Radically Expanding Dilation, "G-RED®" Device
Regulatory Class: II Product Code: GCJ Dated: February 16, 1999 Received: February 17, 1999
Dear Mr. Gaykowski:
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, Drug, and Cosmetic Act (Act). 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.
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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumcs compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 action. In addition, FDA may publish further announcements 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 regulations.
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Page 2 -- Mr. Rick Gaykowski
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.
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
4
510(k) Number (if known):
Device Name: InnerDyne, Inc., Generic Radially Expanding Dilation, G-RED®, Device.
Indications for Use: The InnerDyne, Inc., G-RED® device is intended to provide dilation access for the performance of laparoscopic procedures to establish a port of entry for diagnostic, therapeutic, and operative procedures.
- Percutaneous urological access, for typical procedures such as: .
- Percutaneous nephroscopy .
- Percutaneous bladder access (suprapubic) .
- Percutaneous laparoscopic access to primary body cavities (i.e., . abdominal and thoracic), both primary and secondary punctures; and
- Percutaneous access into hollow body organs. .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-the-Counter Use Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)
InnerDyne, Inc. G-RED® Device Premarket Notification
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