(64 days)
Not Found
No
The document describes a mechanical device with electronic controls for gas output, and explicitly states that AI, DNN, or ML are not mentioned.
No
The device is described as a scope holder and related components for surgical procedures, not as a device intended to treat or diagnose a disease or condition.
No
The device description and intended use indicate that the Kronner Low Profile Scope Holder and its accessories are used for holding scopes and instruments during surgical procedures, not for diagnosing conditions.
No
The device description explicitly mentions hardware components like an electronic control box, solenoids, and gas lines, indicating it is not software-only.
Based on the provided information, none of the listed devices are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use for all the devices is for surgical procedures (abdominal, thoracic, arthroscopic, nasal endoscopic surgery, and holding manual surgical instruments). IVDs are intended for the examination of specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description talks about a scope holder with mechanical and electronic controls, gas lines, and control boxes. This aligns with surgical equipment, not diagnostic tests performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, these devices are surgical instruments and accessories, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
KSH-4 Kronner Low Profile Scope Holder: For abdominal and thoracic endoscopic surgical procedures
HPL2-CRL High pressure* Gas Line Set: For abdominal and thoracic endoscopic and arthroscopic surgical procedures
KSHSA-3 Standard Arm Assembly: For abdominal and thoracic endoscopic surgical procedures
C-1 Control: For abdominal, thoracic, arthroscopic, endoscopic surgery and holding manual surgical instruments
ECB-2 Electronic Control Box: For abdominal, thoracic, arthroscopic, nasal endoscopic surgical procedures and holding manual surgical instruments
GLW-1 Gas line wrench: For abdominal, thoracic, arthroscopic, nasal endoscopic surgical procedures and holding manual surgical instruments
SEAH-1 Small Endoscope Accessory with Handle: For nasal endoscopic surgical procedures
HPL1-BL1-CRL High pressure* Branched Gas Line Set: For nasal endoscopic surgical procedures and holding manual surgical instruments
- Tolerates pressures to 150 PSI, do not use with pressures over 150 psi.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Kronner Low Profile Scope Holder with Electronic Control and Control Box is the same as the Kronner Low Profile Scope Holder (K973543) with mechanical control except that it has an electronic control, momentary button, and electronic control box with solenoids to control gas output.
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
Image /page/0/Picture/0 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" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JUL 2 7 2015
Kronner Prototypes, Inc.
Richard F. Kronner, M.D.
President
1443 Upper Cleveland Rapids Road Roseburg, OR 97470
K000663 Re:
Trade/Device Name: Low Profile Scope Holder Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated (Date on orig SE Itr): February 22, 2000 Received (Date on orig SE ltr): February 28, 2000
Dear Dr. Kronner,
This letter corrects our substantially equivalent letter of May 2, 2000.
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
KOODEES 510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Kronner Low Profile Scope Holder
Indications for Use:
KSH-4 Kronner Low Profile Scope Holder KYOMAET LOW I TOTAC Soupe Works surgical procedures
HPL2-CRL High pressure® Gas Line Set
H. High pressure - Gas Eine Oot
KSHSA-3 Standard Arm Assembly
For abdominal and thoracic endoscopic surgical procedures
C-1 Control
For abdominal, thoracic, arthroscopic, endoscopic surgery and holding manual surgical instruments
ECB-2 Electronic Control Box
For abdominal, thoracic, arthroscopic, nasal endoscopic surgical r of action. Than and holding manual surgical instruments
GLW-1 Gas line wrench
Gas this through, anthroscopic, nasal endoscopic surgical For abounting, mording manual surgical instruments
SEAH-1 Small Endoscope Accessory with Handle
For nasal endoscopic surgical procedures
HPL1-BL1-CRL. High pressure* Branched Gas Line Set
ET-ORL Thyn procedures and holding and holding manual surgical Instruments
· Tolerates pressures to 150 PSI, do not use with pressures over 150 psi.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
e R. Vochner.
Division Restorative Devices
510(k) Number K600663
Prescription Use
(Per 21 CFR 801.109)
27
1999
Over-The-Counter Use _
(Optional Format 1-2-96)
8-2
3
MAY - 2 2000
41
k 000663
510(K) SUMMARY as required by 807.92(c)
4
K00663
KRONNER PROTOTYPES, INC.
1443 Upper Cleveland Rapids Road
Phone: (541) 672-2543
Prepared: February 22, 2000
Contact Person: Richard Kronner, President
દર
5
K 000663
Trade Name: Kronner Low Profile Scope Holder
Common Name: Endoscope Holder
Classification Name: Endoscope holding device (no industry name for this device)
6
000663
Equivalent to legally marketed devices
by
( K973543 ) Kronner Prototypes, Inc.
4
7
Description:
The Kronner Low Profile Scope Holder with Electronic Control and Control Box is the same as the Kronner Low Profile Scope Holder (K973543) with mechanical control except that it has an electronic control, momentary button, and electronic control box with solenoids to control gas output.
4
8
K 000 663
Intended Usage:
KSH-4 Kronner Low Profile Scope Holder
For abdominal and thoracic endoscopic surgical procedures
HPL2-CRL High pressure* Gas Line Set
For abdominal and thoracic endoscopic and arthroscopic surgical procedures
KSHSA-3 Standard Arm Assembly
For abdominal and thoracic endoscopic surgical procedures
C-1 Control
For abdominal, thoracic, arthroscopic, endoscopic surgery and holding manual surgical instruments
ECB-2 Electronic Control Box
For abdominal, thoracic, arthroscopic, nasal endoscopic surgical procedures and holding manual surgical instruments
GLW-1 Gas line wrench
For abdominal, thoracic, arthroscopic, nasal endoscopic surgical procedures and holding manual surgical instruments
SEAH-1 Small Endoscope Accessory with Handle
For nasal endoscopic surgical procedures
HPL1-BL1-CRL High pressure* Branched Gas Line Set
For nasal endoscopic surgical procedures and holding manual surgical instruments
· Tolerates pressures to 150 PSI, do not use with pressures over 150 psi.
9
000663
Summary of technological characteristics of device compared to predicate devices.
The Kronner Low Profile Scope Holder with Electronic control and Electronic Control Box is essentially equivalent to the Kronner Low Profile Scope Holder (K973543) except that the mechanical control has been replaced with an electronic control and electronic control box with solenoids to control gas output.