(75 days)
There are no Predicate Devices mentioned in the provided text.
Not Found
No
The description focuses on manual operation, fiber-optic technology, and materials, with no mention of AI, ML, or related concepts.
Yes
The device is described as being used to "perform various diagnostic and therapeutic procedures" using additional instruments. This explicitly states its therapeutic capability.
Yes
The device is explicitly designed for the "examination of the gall bladder and bile duct," which falls under diagnostic procedures. Additionally, it states its use for "various diagnostic and therapeutic procedures."
No
The device description clearly states it is a "manually operated surgical device" and describes physical components like a flexible fiber-optic telescope, polyurethane body contact portions, and stainless steel accessories (forceps). This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the examination of the gall bladder and bile duct and to perform diagnostic and therapeutic procedures within the body. This is an in-vivo procedure, not an in-vitro (outside the body) diagnostic test.
- Device Description: The device is a flexible fiber-optic telescope used for direct visualization and manipulation within the body. This is characteristic of an endoscopic device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue) outside the body, which is the core function of an IVD.
Therefore, the KSEA 15.5 Fr. Flexible Choledocho-Fiberscope is a surgical/endoscopic device, not an IVD.
N/A
Intended Use / Indications for Use
The KSEA 15.5 Fr. Flexible Choledocho-Fiberscope is designed to be used by qualified surgeons and physicians for examination of the gall bladder and bile duct, and, using additional instruments, to perform various diagnostic and therapeutic procedures.
Product codes
78 FBN
Device Description
The KSEA 15.5 Fr. Flexible Choledocho-Fiberscope is a manually operated surgical device. The Flexible Choledocho-Fiberscope is a flexible fiber-optic telescope which utilizes fiber-optic technology. The body contact portions of the Flexible Choledocho-Fiberscope are composed of medical-grade polyurethane. The Accessories are double-action flexible forceps (grasping and biopsy), which are constructed of surgical-grade stainless steel (AISI series 303 and 304 for the shafts, AISI series 420 for jaws and handles).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gall bladder and bile duct
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons and physicians
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
Karl Storz Endoscopy-America, Inc.
600 Corporate Pointe Culver City, California 90230-7600 Phone 310 558 1500
Toll Free 800 421 0837 Fax 310 410 5527
AUG 1 2 1997
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with This sunanial you s rotaly said Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document are accurate and complete to the best of KSEA's knowledge.
- Karl Storz Endoscopy-America, Inc. Applicant: 600 Corporate Pointe Culver City, CA 90230 (310) 558-1500
Marlena Allen Piercy, Ph.D. Contact: Senior Clinical Affairs Specialist
Device Identification: Common Name: Flexible Choledochoscope and Accessories
Trade Name (optional): KSEA 15.5 Fr. Flexible Choledocho-Fiberscope and Accessories
Indication: The KSEA 15.5 Fr. Flexible Choledocho-Fiberscope is designed to be used by qualified surgeons and physicians for examination of the gall bladder and bile duct, and, using additional instruments, to perform various diagnostic and therapeutic procedures.
Device Description: The KSEA 15.5 Fr. Flexible Choledocho-Fiberscope is a manually operated surgical device. The Flexible Choledocho-Fiberscope is a flexible fiber-optic telescope which utilizes fiber-optic technology. The body contact portions of the Flexible Choledocho-Fiberscope are composed of medical-grade polyurethane. The Accessories are double-action flexible forceps (grasping and biopsy), which are constructed of surgical-grade stainless steel (AISI series 303 and 304 for the shafts, AISI series 420 for jaws and handles).
Substantial Equivalence: The KSEA 15.5 Fr. Flexible Choledocho-Fiberscope is substantially equivalent to the predicate devices since the basic features, design, and intended uses are the same. The minor differences between the KSEA 15.5 Fr. Flexible Choledocho-Fiberscope and Accessories and the predicates devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function, or intended use of the devices.
Signed: Marlena Allen Piercy, Ph.D.
Senior Clinical Affairs Specialist
000073
..
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 1997
Re: K971977
Mr. Kevin A. Kennan Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230-7600
15.5 Fr. Flexible Choledocho-Fiberscope Dated: May 28, 1997 Received: May 29, 1997 Regulatory class: II 21 CFR §876.1500/Product code: 78 FBN
Dear Mr. Kennan:
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 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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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) 594-4613. 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,
h. Lillian Yip, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/2/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is in white text on a black background. The word "STORZ" is in large, bold letters, with a circle in the middle of the "O". Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller font.
510(k) Number (if known): Not-yet-assigned. K971977
Device Name: 15.5 Fr. Flexible Choledocho-Fiberscope
Indications for Use:
The 15.5 Fr. Flexible Choledocho-Fiberscope is indicated for examination of the gall The 15.5 FT. Ficable Chorodocio 11.000poories, to perform diagnostic and therapeutic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE -
CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of Reproductive, Abdominal, Er T., |
| and Radiological Devices |
| 510(k) Number | K971977 |
|---|---|
| Prescription Use: | X |
| OR Over-the-Counter Use: |
(Per 21 CFR 801.109) (Optional Format 1-2-96)
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