(34 days)
Like the predicate devices, the BAHO autoclavable Cystoscope is indicated for use in the visual examination of body cavities, hollow organs and canals and using additional accessories, to perform various diagnostic and therapeutic procedures.
The BAHO autoclavable Cystoscope has a basic design similar to those legally available for sale in the U.S.A. Like others legally sold in the U.S.A.,it consists of an evepiece.body and insertion tube. The insertion tube is double walled surgical steel with illumination fibers in between. The insertion tube contains the optical rod lens system. ( identical to BAHO autoclavable Laparoscope 510(k) Number K982276 )
The provided text describes a 510(k) submission for a medical device (BAHO Autoclavable Cystoscope) and focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance data and acceptance criteria from a study.
Therefore, many of the requested data points (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not available in the provided text, as they are not typically part of a 510(k) submission that relies on demonstrating equivalence through material and design similarity to already approved devices.
Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Design Equivalence | Basic design similar to legally available devices in the U.S.A. (eyepiece, body, insertion tube, double-walled surgical steel with illumination fibers, optical rod lens system). | "The BAHO autoclavable Cystoscope has a basic design similar to those legally available for sale in the U.S.A. Like others legally sold in the U.S.A., it consists of an eyepiece, body and insertion tube. The insertion tube is double walled surgical steel with illumination fibers in between. The insertion tube contains the optical rod lens system." (identical to K982276) |
| Material Equivalence | Selection of materials demonstrating appropriate levels of biocompatibility, similar or identical to predicate devices and other approved BAHO endoscopes. | "The biological safety of the BAHO autoclavable Cystoscope has been defined through the selection of materials that demonstrated appropriate levels of biocompatibility which constitute the building blocks of the proposed device. These materials are similar or identical to those used for the manufacturing of the predicate devices as well as other brands legally sold in the U.S.A. and other approved BAHO endoscopes (Arthroscope, Laparoscope)" |
| Functional Equivalence | Biocompatibility, function, indications, and designs developed to ensure safety and substantial equivalence to commercially approved cystoscopes. | "In summary : biocompatibility, function, indications and designs have been developed to ensure the safety of this device. It is substantially equivalent to commercially approved cystoscopes available for sale in the U.S.A." |
| Indication for Use | Indicated for visual examination of body cavities, hollow organs, and performing diagnostic/therapeutic procedures with accessories. | "Like the predicate devices the BAHO autoclavable Cystoscope is indicated for use in the visual examination of body cavities, hollow organs and using additional accessories, to perform various diagnostic and therapeutic procedures." |
2. Sample sized used for the test set and the data provenance
- Sample Size: Not applicable/Not provided. The submission relies on claiming substantial equivalence based on material and design similarity to existing predicate devices, not on a new testing study with a "test set" in the context of performance metrics for an AI/diagnostic device.
- Data Provenance: Not applicable/Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. No dedicated "test set" requiring expert-established ground truth is mentioned. The submission is about device design and materials.
4. Adjudication method for the test set
- Not applicable/Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable/Not provided. This is not a diagnostic device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is a physical, optical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. The "ground truth" for this submission is the established safety and efficacy of the predicate devices and the biocompatibility of the materials used in the new device, rather than diagnostic accuracy.
8. The sample size for the training set
- Not applicable/Not provided. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not provided.
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OCT 7 1999
SUMMARY OF SAFETY AND EFFECTIVENESS
4992983
1
BAHO INNOVATIVE MEDIZINTECHNIK, GmbH Autoclavable Cystoscopes
1) Submitter Information :
| Name and Address : | Innovative Endoscopy Components, LLC1112 Weston Road, PMB 227Ft. Lauderdale, FL 33326 |
|---|---|
| Telephone : | (954) 217-8780 |
| Fax : | (954) 217-8781 |
| E-mail : | IECflorida@aol.com |
| FDA Registration No. | 1064152 |
- Manufacturer Information : BAHO Innovative Medizintechnik GmbH
Im Stoeckacker 7
D- 79224 Umkirch
Germany
| Telephone : | (011)49-7665-99094 |
|---|---|
| Fax : | (011)49-7665-99095 |
| FDA Registration No. | 9615001 |
| FDA Owner/Operator No. | 9026517 |
- Device Name :
| Classification Name | CystoscopeIdentical Materials,Components and Procedures asBAHO autoclavable Laparoscope 510(k) Number K982276 |
|---|---|
| Classification Number | 876.1500 ( Class II Device ) |
| Proprietary Name | BAHO autoclavable Cystoscope |
- Predicate Device : Storz Model # 27005
Wolf Model # 8650.../8660...
| Manufacturer : | Karl Storz | Richard Wolf |
|---|---|---|
| Mittelstrasse 8 | Postfach 1164 | |
| Postfach 230 | D-75434 Knittlingen | |
| D-4200 Tuttlingen | Germany | |
| Germany |
{1}------------------------------------------------
The above identified predicate devices have the basic design and technological features equivalent to those in the proposed BAHO autoclavable Cystoscope.
K992983
pg 2 of 2
-
- Description of Device :
The BAHO autoclavable Cystoscope has a basic design similar to those legally available for sale in the U.S.A. Like others legally sold in the U.S.A.,it consists of an evepiece.body and insertion tube. The insertion tube is double walled surgical steel with illumination fibers in between. The insertion tube contains the optical rod lens system. ( identical to BAHO autoclavable Laparoscope 510(k) Number K982276 )
- Description of Device :
-
- Indication for use :
Like the predicate devices the BAHO autoclavable Cystoscope is indicated for use in the visual examination of body cavities, hollow organs and using additional accessories, to perform various diagnostic and therapeutic procedures.
- Indication for use :
-
- Description of safety and substantial equivalence :
The biological safety of the BAHO autoclavable Cystoscope has been defined through the selection of materials that demonstrated appropriate levels of biocompatibility which constitute the building blocks of the proposed device.
- Description of safety and substantial equivalence :
These materials are similar or identical to those used for the manufacturing of the predicate devices as well as other brands legally sold in the U.S.A. and other approved BAHO endoscopes ( Arthroscope, Laparoscope )
-
- Summary
In summary : biocompatibility, function, indications and designs have been developed to ensure the safety of this device.It is substantially equivalent to commercially approved cystoscopes available for sale in the U.S.A.
- Summary
{2}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1999 OCT
Mr. Gerald Goigitzer Managing Director Innovative Endoscopy Components, LLC 1112 Weston Road. Suite 227 Ft. Lauderdale, Florida 33326
Re: K992983 BAHO Autoclavable Cystoscope Dated: August 21, 1999 Received: September 3, 1999 Regulatory Class: II 21 CFR §876.1500/Procode: 78 FAJ
Dear Mr. Goigitzer:
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 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). 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 vour 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 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 requlation 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.
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 requlation (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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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of Page /
510(k) Number (if known): K992983
Device Name: BAHO AUTOCLAVABLE CYSTOSCOPE
Indications For Use:
Like the predicate devices, the BAHO autoclavable Cystoscope is indicated for use in the visual examination of body cavities, hollow organs and canals and using additional accessories, to perform various 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)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Yhird le. Sypm
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devic
510(k) Number.
§ 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.