(92 days)
Indications: This instrument is indicated for use with a compatible trumpet valve during endoscopic surgery for facilitating the removal of gallstones.
The stone extractor has a nominal diameter of 0.392", a tube length of 13.0" and has a scoop 0.6" long. The surface of the stone extractor is polished on the proximal 3.0" and matte finished on the remaining 10.0". The stone extractor is fabricated from 304 stainless steel.
The provided text is a 510(k) summary for a medical device (Stone Extractor) submitted in 1997. This type of submission relies on demonstrating "substantial equivalence" to a predicate device already on the market, rather than conducting new clinical studies with defined acceptance criteria and performance metrics typically associated with AI/software devices today.
Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, or AI performance metrics. The text focuses on comparing the new device's physical attributes and intended use to a legally marketed predicate device.
Specifically:
- A table of acceptance criteria and the reported device performance: Not applicable. The submission is a comparison of attributes to a predicate device, not a performance study against predefined criteria.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set or clinical study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. No test set or ground truth establishment is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication process is described.
- 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. This device is a physical stone extractor, not an AI or software device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical stone extractor.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth is established as there is no performance study.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
The 510(k) summary explicitly states its purpose is to demonstrate "Substantial Equivalence" based on a comparison of device attributes and intended use. The provided table compares specific attributes of the submitted device to a predicate device, showing identical or similar specifications (e.g., material, dimensions, reusability, sterility). This comparison is the "study" for a 510(k) of this nature. The FDA's letter (K971123) confirms substantial equivalence, which allows the device to be marketed.
{0}------------------------------------------------
PHX Technologies Corporation
Post Office Box 1059, Lewisville, Texas 75067 (817)387-5696 FAX (817)382-0577
510(K) Summary
Date: 21 March 1997
Trade Name: Stone Extractor
Common Name: Stone Extractor
Classification Name: Unknown
Device Description: The stone extractor has a nominal diameter of 0.392", a tube length of 13.0" and has a scoop 0.6" long. The surface of the stone extractor is polished on the proximal 3.0" and matte finished on the remaining 10.0". The stone extractor is fabricated from 304 stainless steel.
Intended Use: This stone extractor is indicated for use in laproscopic surgery for the removal of gall stones.
Substantial Equivalence: This stone extractor, Submitted Device is, substantially equivalent to the stone extractor, Predicate Device, currently being sold in the United States by American Hydro-Surgical Instruments, Inc., 430 Commerce Drive, Delray, Florida 33445 To the best of our knowledge, this predicate devices is being "legally" marketed.
Comparison to Predicate Device:
| Attribute | Predicate Device | Submitted Device |
|---|---|---|
| Material of construction, Stone extractor | Stainless steel | Stainless steel |
| laterial of construction, handle | Aluminum | Stainless steel |
| Stone extractor, nominal diameter, inches | 0.392" | 0.392 |
| Stone extractor, nominal length, inches | 13.0" | 13.0" |
| Stone extractor, nominal length, Scoop,inches | 0.6" | 0.6" |
| Reuseability | Reuseable | Reuseable |
| Sterility | Sold non-sterile | Sold non-sterile |
| Submitter's Name | PHX Technologies Corporation | |
| Submitter's Address: | 1032 Shady Oaks Drive, No. 100, Denton, TX 76205 |
Submitter's Phone #: Submitter's FAX: Submitter's Contact Person:
(817) 387-5696 (817) 382-0577 James F. Chapel JUN 27 1997
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 1997
Mr. James F. Chapel President PHX Technologies Corporation P.O. Box 1059 Lewisville, Texas 75067
Re: K971123
Stone Extractor Dated: May 13, 1997 Received: May 19, 1997 Regulatory class: II 21 CFR §876.1500/Product code: 78 KOG
Dear Mr. Chapel:
We have reviewed your Section 510(k) notification of intent to market the device 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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) 594-4616. 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,
hihai Yi
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
Enclosure
{2}------------------------------------------------
Page 1 of 1
510(k) Number (if known): K971123
Device Name: Billiary Stone Extractor
Indications For Use:
Indications: This instrument is indicated for use with a compatible trumpet valve during endoscopic surgery for facilitating the removal of gallstones.
Contraindications: This instrument is contraindicated for use when, in the judgment of the physician, it's use would be contrary to the best interest of the patient.
Precautions: During surgery this instrument must be handled with care to avoid misuse and possible damage. Use care when passing this instrument through a cannula. When inserting the instrument into a cannula that has a hinged valve, make sure that the valve is fully open. When removing the instrument from a cannula that has a hinged valve, make sure that the valve is fully open and pull the instrument straight out, as lateral or side movement may cause the tip to hang on the vaive.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rokerp Sathing/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K971123
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.