(258 days)
Not Found
No
The document describes a standard flexible fiberscope and associated instruments, focusing on mechanical and optical features. There is no mention of AI, ML, or advanced image processing beyond basic resolution enhancement.
Yes
The "Intended Use / Indications for Use" section explicitly states "For examination, diagnosis, and/or therapy in connection with Flexible Fiberscope." The inclusion of "therapy" directly indicates it's a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Flexible Fiberscope is for "examination, diagnosis, and/or therapy." This directly indicates its role in diagnostic procedures.
No
The device description clearly outlines physical components like an eyepiece, focusing ring, lever, flexible insertion portion, and a sheath with active deflection, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a flexible fiberscope used for examination, diagnosis, and/or therapy directly within the lumbar spine. It involves direct visualization and the use of instruments like biopsy forceps and electrodes within the body.
- Lack of Sample Analysis: There is no mention of analyzing samples taken from the patient outside of the body. The device is used for direct intervention and observation.
The device is an endoscopic device used for minimally invasive procedures within the lumbar spine.
N/A
Intended Use / Indications for Use
Flexible Fiberscope: For examination, diagnosis, and/or therapy in connection with Flexible Fiberscope. Tor exammation, chughts used through the working channel of the instrument for use in lumbar spine applications.
Flexible Biopsy Forcep: Used to obtain small biopsies from tissue
Electrodes: Used for unipolar coagulation.
Flexible fiberscopes are used for examination, diagnosis, and/or therapy in connection with endoscopic accessories and auxiliary instruments used through the working channel of the instrument for use in lumbar spine applications.
Product codes
HRX, KOG
Device Description
The flexible endoscope consists of an eyepiece, with a focusing ring for direct view or connection to a video camera, a lever to control the flexible tip of the scope, and the flexible insertion portion.
Mentions image processing
The image is transmitted via objective, fiber bundle and eyepiece for direct view or connection to a video camera. The total number of pixels and the fibers per mm² are increased to get an image with higher resolution.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The instruments are designed to be used by adequately trained and qualified medical personnel . in the fields of spine, urology, surgery, gynecology, and ENT.
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)
No known FDA performance standard exists. Clinical tests performed were not performed. These devices are designed and tested to assure their safety and effectiveness when used according to the instructions manual.
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
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
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Image /page/0/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
MEMORANDUM
Food and Drug Administration Office of Device Evaluation 10903 New Hampshire Avenue Silver Spring, MD 20904
Premarket Notification [510(k)] Review Corrected Substantial Equivalence Letters - New Product Codes
K990397
Date: 1/30/2014 To: The Record From: Tuan Nguyen, Biomedical Engineer Office: ODE Division: DRGUD Branch: ULDB
510(k) Holder: K990397
Flexible Fiberscopes and Accessories Device Name:
Kellie Straughn (Clerk Typist), DRGUD
Previous Product Code: HRX, KOG
New Product Code: HRX
The product code KOG Endoscope and/or accessories under the requlation 876.1500 Endoscope and accessories has been used extensively to include a large variety of medical devices associated with endoscopes. Subsequent to the generation of KOG additional product codes have been generated that group similar devices into more specific groups. It was decided that the product code KOG would be no longer used and that all endoscopes and/or accessories would use the more specific product codes.
Ms Cheryl Mackey (Program Analyst, DRUGD) identified the past 510(k)s that included the product code KOG, and Ms Christine Lee (Assistant Director Program Operations, DRGUD) assigned the new procode(s). Correction letters will be generated by Kellie Straughn (Clerk Typist) to update these devices using the new product codes.
Tuan Nguyen -A 2014.01.30 09:42:53 -05'00'
Tuan Nguyen, Biomedical Engineer, ULDB
1/30/2014 Date
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| Digital Signature Concurrence Table | |
|---|---|
| Reviewer Sign-Off | Christine Lee |
| Branch Chief Sign-Off | Glenn Bell |
| Division Sign-Off | Benjamin R. Fisher -S |
Template Name: Corrected Substantially Equivalent Letter: Classified and Not Classified; v2013-04-02
------------- REMOVE BELOW WHEN USING TEMPLATE --------------
Template History:
| Date of Update | By | Description of Update |
|---|---|---|
| 7/27/09 | Brandi Stuart | Added Updates to Boiler Table |
| 8/7/09 | Brandi Stuart | Updated HFZ Table |
| 9/25/12 | Edwena Jones | Added digital signature format |
| 12/12/2012 | Margaret McCabe | |
| Janicki | One digit was missing from 4-digit ZIP code extension in letterhead ("002" should read | |
| "0002"). Revised to fix this. | ||
| 04/02/2013 | Sara Aguel | Clarified letter instructions; added OIR option in signature block. Added option for IVD |
| labeling regulation. Edited sentence that starts "If you desire specific advice for your | ||
| device on our labeling regulation (21 CFR Part 801)..." Replaced broken Compliance | ||
| link with general link to DSMICA. Added sentence that starts "Please note: CDRH does | ||
| not evaluate information related to contract liability warranties..." to be consistent with | ||
| language in K1(A) SE letter. Added instructions to "Re: [510(k) NUMBER]" section to | ||
| be consistent with language in KI(A) SE letter. | ||
| 4/12/2013 | Margaret McCabe | |
| Janicki | Fixed typos in paragraph 1, final sentence: "We remind you; however, that...misleading" |
-
replaced the incorrect semicolon with a comma and added a period at the end of the
sentence. | -
cc: DCC – sign-off & original ODE/DRGUD/ULDB – (GBB)
Final: KAS:kas
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JUL 2 7 2015
Richard Wolf Medical Instruments Corporation Mr. Robert L. Casarsa Quality Assurance Manager 353 Corporate Woods Parkway Vernon Hills, IL 60061
Re: K990397 Trade/Device Name: Flexible Fiberscopes and Accessories Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated (Date on orig SE ltr): August 11, 1999 Received (Date on orig SE ltr): August 12, 1999
Dear Mr. Casarsa,
This letter corrects our substantially equivalent letter of October 25, 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
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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 (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/Resourcesfor You/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
4
| 510(k) Number (if known): | K990397 |
|---|---|
| --------------------------- | --------- |
Flexible Fiberscopes and Accessories Device Name:__________________________________________________________________________________________________________________________________________________________________
Intended Use:
Flexible Fiberscope: For examination, diagnosis, and/or therapy in connection with Flexible Fiberscope. Tor exammation, chughts used through the working channel of the instrument for use in lumbar spine applications.
Flexible Biopsy Forcep: Used to obtain small biopsies from tissue
Electrodes: Used for unipolar coagulation.
Field of Application:
The instruments are designed to be used by adequately trained and qualified medical personnel . in the fields of spine, urology, surgery, gynecology, and ENT.
IMPORTANT! The product dimensions must correspond with the anatomic proportions, i.e., the correct flexible fiberscope must be selected for the medical procedure.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
scally
General Restorative Devic
Prescription Use
Per 21 CFR 801.109
Over-The Counter_
5
OCT 2 5 1999
I
353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Phone: 847.913.1113 Fax: 847.943.1488
RICHARD WOL
H
MEDICAL INSTRUMENTS CORPORATIO
510(k) Summary of Safety and Effectiveness
| Date of Preparation: | February 5, 1999 |
|---|---|
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| FDA establishment registration number: | 14 184 79 |
| Division name (if applicable): | N.A. |
| Phone number (include area code): | (847) 913-1113 |
| Street address: | 353 Corporate Woods Parkway |
| FAX number (include area code): | (847) 913-0924 |
| City: | Vernon Hills |
| State/Province: | Illinois |
| Country: | USA |
| ZIP / Postal Code: | 60061 |
| Contact name: | Mr. Robert L. Casarsa |
| Contact title: | Quality Assurance Manager |
Product Information:
| Trade name: | Flexible fiberscopes and accessories |
|---|---|
| Model number: | 7265.001, 7305.xxx, 7321.xxx, 7325.xxx, 7330.xxx |
| Common name: | Flexible fiberscopes |
| Classification name: | Flexible endoscopes |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer | |
|---|---|---|---|
| 1 | K962172 | Flexible Mini-Fiberscopes | Richard Wolf |
| 2 | LASE Flexible Endoscope | Clarus | |
| 3 | K971455 | SITEprobe diagnostic spinal endoscope | Clarus |
| 4 | K946087 | The Inclusive TM Endoscope System | Sofamor Danek |
1.0 Description
The flexible endoscope consists of an eyepiece, with a focusing ring for direct view or connection to a video camera, a lever to control the flexible tip of the scope, and the flexible insertion portion.
2.0 Intended Use
: 2
Flexible fiberscopes are used for examination, diagnosis, and/or therapy in connection with endoscopic accessories and auxiliary instruments used through the working channel of the instrument for use in lumbar spine applications.
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Image /page/6/Picture/1 description: The image shows a black square with a white symbol inside. The symbol appears to be a stylized or abstract representation of a dog or wolf-like creature. The symbol is simple and geometric, with sharp lines and angles.
3.0 Technological Characteristics
There are no significant technological changes or characteristics to the new devices compared to the existing devices.
The tip of the sheath has an active deflection up to 360°, depending on the fiberscope. The deflecting position can be locked with a brake on some fiberscopes. The image is transmitted via objective, fiber bundle and eyepiece for direct view or connection to a video camera. The total number of pixels and the fibers per mm² are increased to get an image with higher resolution. Biopsy material can be taken by the wide working channel, which is simultaneously used for irrigation. Auxiliarv instruments such as forceps are inserted via a proximal mounted insertion cock with supply and discharge.
4.0 Substantial Equivalence
The submitted devices pose the same type of questions about safety or effectiveness as the compared devices. The new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing pre-enactment and 510(k) devices sold by Richard Wolf in the urology branch. In addition, the submitted devices are substantially equivalent to devices sold by Clarus, and Sofamor Danek.
5.0 Performance Data
No known FDA performance standard exists.
6.0 Clinical Tests
Clinical tests performed were not performed.
7.0 Conclusions Drawn
These devices are designed and tested to assure their safety and effectiveness when used according to the instructions manual.
By: Robert L. Casassa
Robert L. Casarsa Quality Assurance Manager
Date: Feb 5, 99