The Stone Grasping Basket is a medical device indicated for use by qualified surgeons in the treatment of salivary gland diseases. It is used endoscopically to entrap and remove mobile stones and stone fragments smaller than 5mm from the salivary gland.

Device Description

The stone grasping basket is a 30mm long, 4 wire, 10mm Nitinol Stone removal Basket, which is designed to pass through low diameter working channels of endoscopes for the purpose of retrieval of stones from the salivary gland.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Sialo Modular Stone Grasping Basket, which is a medical device for removing stones from salivary glands. However, the document does not contain the detailed information necessary to complete the table and specific questions about acceptance criteria and a study proving device performance as requested.

Here's a breakdown of what is and is not in the document:

What is in the document:

Device Description: A 30mm long, 4-wire, 10mm Nitinol Stone removal Basket designed for salivary gland stone removal.
Intended Use/Indication for Use: Used endoscopically by qualified surgeons to entrap and remove mobile stones and stone fragments smaller than 5mm from the salivary gland.
Predicate Devices: Several previously approved stone baskets from Karl Storz Endoscopy, Millennium Devices Inc., and Cook Inc.
Performance Standards: None mentioned.
Test Data: "The Stone Grasping Basket device has been subjected to safety and performance testing before release. Testing of the device included various performance tests designed to ensure that the device meets all its functional specifications and complies with safety standards." This is a general statement, not a detailed report.
Substantial Equivalence Conclusion: "The results of the performance tests demonstrate that the stone grasping basket meets its specifications for efficacy and exhibits similar physical properties as the predicate devices."

What is NOT in the document (and therefore cannot be provided in the answer):

Specific acceptance criteria (numerical thresholds, success rates, etc.)
Reported device performance against specific criteria.
Details of the study that proves the device meets acceptance criteria.
Sample size used for the test set or its provenance.
Number of experts, their qualifications, or adjudication methods for ground truth establishment.
Information about MRMC studies or effect sizes.
Information about standalone (algorithm-only) performance.
Type of ground truth used (e.g., pathology, outcomes data).
Sample size for the training set (as this is a mechanical device, not an AI/algorithm-based one, a "training set" in the machine learning sense is not applicable).
How ground truth for the training set was established.

Based on the provided text, here is what can (and cannot) be answered:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance (Not Explicitly Stated)
Specific functional specifications (e.g., basket opening diameter accuracy, grasping force, material integrity, steerability, maximum stone size removal, compatibility with endoscope channels, durability)	General statement: "device meets all its functional specifications and complies with safety standards."
Safety standards compliance (e.g., biocompatibility, sterility, absence of sharp edges)	General statement: "complies with safety standards."
Similar physical properties to predicate devices	General statement: "exhibits similar physical properties as the predicate devices."
Efficacy in entrapping and removing stones <= 5mm	General statement: "meets its specifications for efficacy."

(Note: The document only provides a high-level statement that the device meets "functional specifications" and "safety standards" and has "similar physical properties" to predicate devices. It does not list specific criteria or performance metrics.)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not provided. The document states "The Stone Grasping Basket device has been subjected to safety and performance testing before release," but gives no details about the sample size, type of test specimens (e.g., artificial stones, animal models, clinical cases), or the provenance of any data.

3. 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/Not provided. This device is a mechanical tool for physical stone removal. The concept of "ground truth" established by experts in the context of diagnostic interpretation (like radiology) does not apply here. The "performance tests" would likely involve engineering tests on the device itself and potentially in vitro models.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/Not provided. (See #3 explanation).

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

No. This is a mechanical surgical instrument, not an AI or diagnostic imaging device. An MRMC study is not relevant to its type of performance assessment.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No. This is a mechanical surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not clearly defined in the document. For a mechanical device, "ground truth" for performance would typically be based on objective physical measurements (e.g., basket diameter, wire tensile strength, grasping force), and observed success/failure in controlled in-vitro or benchtop tests using simulated stones or materials, rather than expert consensus on diagnostic images or pathology reports.

8. The sample size for the training set

Not applicable. This is a mechanical device, not a machine learning algorithm, so there is no "training set" in that sense. The design and development process for such a device would involve iterative prototyping and testing, but not a "training set" as understood in AI/ML performance studies.

9. How the ground truth for the training set was established

Not applicable. (See #8 explanation).

Summary

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MAR 1 3 2009

510(K) SUMMARY

SIALOTECH MODULAR STONE GRASPING BASKET

510(k) Number K082735

Applicant's Name:

Sialo Technology Ltd. Suite 220 11 Ben Gurion Boulevard Ashkelon 78182 Israel Tel: +972-8-6710795 Fax: +972-9-6782524 e-mail: reuven@sialotechnology.com
Contact Person:

Ahava Stein/ Eyal Ozeri A. Stein - Regulatory Affairs Consulting 20 Hata'as St. -Kfar Saba 44425 Israel Tel. + 972-9-7670002 Fax. +972-9-7668534 e-mail: ahava@asteinrac.com or eyal(@asteinrac.com

Date Prepared: Trade Name:

September 14, 2008 Sialo Stone Grasping Basket

Classification Name: CFR Classification section 876.1500 (Product code GCJ)

Class II medical Device Classification:

The Sialo Modular Stone Grasping Basket device is comparable to Predicate Device: the following predicate devices:

Stone basket of KSEA Sialoendoscope (K012527) manufactured by Karl Storz Endoscopy.
Stone Basket for Midiview series (K051073) manufactured by Millennium Devices Inc.
Wittich Nitinol Stone Basket (K902944) manufactured by Cook Inc

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The stone grasping basket is a 30mm long, 4 wire, 10mm Nitinol Device Description: Stone removal Basket, which is designed to pass through low diameter working channels of endoscopes for the purpose of retrieval of stones from the salivary gland.

Intended Use / Indication for Use:

Performance Standards: None.

The Stone Grasping Basket device has been subjected to safety and Test Data: performance testing before release. Testing of the device included various performance tests designed to ensure that the device meets all its functional specifications and complies with safety standards.

Substantial Equivalence:

The Sialo Stone Grasping Basket device is similar to the currently distributed endoscopic accessory devices intended for stone removal, such as the basket accessory of the Karl Storz KSEA Sialoendoscope (K012527), the stone basket of Midiview series (K051073) manufactured by by Millennium Devices Inc. and the Wittich Nitinol Stone Basket (K902944).

The device has the same intended use and uses the same basic technology as the predicate devices.

The results of the performance tests demonstrate that the stone grasping basket meets its specifications for efficacy and exhibits similar physical properties as the predicate devices.

The conclusions drawn from the above Performance Testing and Conclusions: comparison to predicate devices, is that the Sialo Stone Grasping Basket device is substantially equivalent to the predicate devices listed above.

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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 is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring an abstract design of an eagle or bird-like figure.

MAR 1 3 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sialo Technologies Ltd. c/o Ms. Ahava Stein General Manager, A. Stein - Regulatory Affairs Consulting Ltd. Beit Hapa'amon (Box 124) 20 Hata'as St. 44425 Kfar Saba, Israel

Re: K082735

Trade/Device Name: Stone Grasping Basket Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Il Product Code: GCJ Dated: February 25, 2009 Received: March 3, 2009

Dear Ms. Stein:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Malvina B. Egleston, and

Malvina B. Eydelman, M.D Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K082.735

Sialo Modular Stone Grasping Basket 510(k)

INDICATIONS FOR USE

510(k) Number (if known): K082735

Sialo Stone Grasping Basket Device Name:

Intended Use Statement:

Prescription Use (Per 21 C.F.R. 801 Subpart D) C)

Over-The-Counter Use (Optional Format Subpart

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel C. Olson

(Division Sign-Off) Division of Ophthalmic and Ear. Nose and Throat Devices

082735 510(k) Number

Regulation Number and Section

§ 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.