(116 days)
Not Found
No
The device description focuses on mechanical linkages, a telescoping arm, and nitrogen gas for locking, with no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is a surgical tool holder and does not directly provide therapy; it assists in endoscopic surgical procedures.
No
The device is described as an endoscope holder used during surgical procedures, which is a therapeutic or assistive device, not one that generates diagnostic information.
No
The device description clearly states it consists of "mechanical linkages" and uses "inert nitrogen gas" to operate, indicating it is a physical, hardware-based device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Kronner Low Profile Scope Holder is a mechanical device used to hold a rigid endoscope during surgical procedures. It physically manipulates and positions the endoscope, but it does not analyze or test any biological samples.
- Intended Use: The intended use is for supporting endoscopes during surgical procedures, not for diagnostic testing of samples.
Therefore, based on the provided information, the Kronner Low Profile Scope Holder is a surgical accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Kronner Low Profile Scope Holder is used to hold rigid endoscopes during endoscopic surgery and to allow rapid position changes by the pressing of a control button by the operator.
KLH-100 Kronner Low Profile Scope Holder For abdominal, thoracic, arthroscopic and nasal endoscopic surgical procedures.
HPL-2-30 High pressure flexible gas line set, double output For abdominal, thoracic, arthroscopic endoscopic surgical procedures.
HPL-3-30 High pressure flexible gas line set, triple output For nasal endoscopic surgical procedures.
KLH-200 Arm assembly For abdominal, thoractic, arthroscopic and nasal" endoscopic surgical procedures. *requires the Small Endoscope Accessory
C-100 Arm assembly For abdominal, thoracic, anthroscopic and nasal endoscopic surgical procedures.
C-101 Control strap, replacement For abdominal, thoracic, arthroscopic and nasal endoscopic surgical procedures.
SG-101 Scope grip strap, replacement For abdominal, thoracic, anthroscopic and nasal endoscopic surgical procedures.
SMA-100 Small Endoscope Accessory For nasal endoscopic surgical procedures
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Kronner Low Profile Scope Holder consists of mechanical linkages that connect between the operating table side rail and the shaft or head of a rigid endoscope. A telescoping arm distinguishes the device from other endoscope holders. Inert nitrogen gas at 100-150 psi is used to provide the energy to multiple joints to lock the holder in position when a control button is released by the operator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, thoracic, arthroscopic, nasal
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): 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
JAN | 2 |998
11-97 3543
510(K) SUMMARY
as required by 807.92(c)
: ਹੋੜਾ
a
1
KRONNER PROTOTYPES, INC.
1443 Upper Cleveland Rapids Road Roseburg, Oregon 97470 Phone: (541) 672-2543 FAX: (541) 672-1074 E-mail: kronner@rosenet.net .
:
స
27
Prepared: September 8, 1997
Contact Person: Crystal Kronner, Secretary
1
2
Trade Name: Kronner Low Profile Scope Holder
Common Name: Endoscope Holder
Classification Name: Endoscope holding device, (no industry name for this device)
i
3
Equivalent to legally marketed devices
· :: :: :
જ
का प
by
( K951854 ) Leonard Arm
4
Description:
The Kronner Low Profile Scope Holder consists of mechanical linkages that connect between the operating table side rail and the shaft or head of a rigid endoscope. A telescoping arm distinguishes the device from other endoscope holders. Inert nitrogen gas at 100-150 psi is used to provide the energy to multiple joints to lock the holder in position when a control button is released by the operator.
5
Intended Usage:
The Kronner Low Profile Scope Holder is used to hold rigid endoscopes during endoscopic surgery and to allow rapid position changes by the pressing of a control button by the operator.
6
Summary of technological characteristics of device compared to predicate devices.
The Kronner Low Profile Scope Holder is essentially equivalent to the Leonard Arm, except that it has a telescoping arm instead of an arm with a hinge joint, and uses nitrogen gas pressure as an energy source to hold position rather than vacuum.
The Kronner Low Profile Scope Holder uses flexible lines and a control which can be attached to the camera to supply and control the energy used to lock the joints. These features are built into the Leonard Arm.
7
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 1998
Ms. Crystal Kronner *Secretary Kronner Prototypes, Incorporated 1443 Upper Cleveland Rapids Road Roseburg, Oregon 97470
Re: K973543
Trade Name: Kronner Low Profile Scope Holder Regulatory Class: II Product Code: GCJ Dated: December 11, 1997 Received: December 29, 1997
Dear Ms. Kronner:
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 assumes compliance with the current Good Manufacturing Practice requirements , 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
8
Page 2 - Ms. Kronner
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 vours.
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
9
Indications For Use:
KLH-100 Kronner Low Profile Scope Holder
For abdominal, thoracic, arthroscopic and nasal endoscopic surgical procedures.
HPL-2-30 High pressure flexible gas line set, double output
For abdominal, thoracic, arthroscopic endoscopic surgical procedures.
HPL-3-30 High pressure flexible gas line set, triple output
For nasal endoscopic surgical procedures.
KLH-200 Arm assembly
For abdominal, thoractic, arthroscopic and nasal" endoscopic surgical procedures.
*requires the Small Endoscope Accessory
C-100 Arm assembly
For abdominal, thoracic, anthroscopic and nasal endoscopic surgical procedures.
C-101 Control strap, replacement
For abdominal, thoracic, arthroscopic and nasal endoscopic surgical procedures.
SG-101 Scope grip strap, replacement
For abdominal, thoracic, anthroscopic and nasal endoscopic surgical procedures.
SMA-100 Small Endoscope Accessory
For nasal endoscopic surgical procedures
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Division of General Restorative Devices
510(k) Number K973543
Prescription Use
(Per 21CFR 801.109)
10
Over-The-Counter Use
8-1
OR