(333 days)
Not Found
Not Found
No
The summary describes a physical drainage catheter and does not mention any computational or analytical functions that would typically involve AI/ML.
Yes.
The device is used for the treatment of salivary gland diseases for the purpose of drainage, which is a therapeutic action.
No
The Intended Use/Indications for Use section states the device is for the "treatment of salivary gland diseases for the purpose of drainage," and to "allow continuous drainage of saliva and/or fluid irrigation." This clearly describes a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a flexible, single lumen, sterile, single use, disposable cannula made of biocompatible radio-opaque polyurethane material, which is a physical hardware component.
Based on the provided information, the Sialo Drain is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for the "treatment of salivary gland diseases for the purpose of drainage." This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical cannula for insertion into the body, not reagents, instruments, or software used to examine samples.
- Anatomical Site: It's used directly within the salivary gland and duct, which are parts of the body, not samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like saliva, blood, etc.) to provide diagnostic information. The device's function is purely mechanical drainage.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Sialo Drain does not fit this description.
N/A
Intended Use / Indications for Use
The Sialo Drain is a medical device for use by qualified surgeons in the treatment of salivary gland diseases for the purpose of drainage.
The Sialo Drain is an intraoral/extraoral drainage catheter, intended to allow continuous drainage of saliva and/or fluid irrigation of the salivary duct by temporary insertion into the salivary gland, whether orally or through the cheek.
Product codes (comma separated list FDA assigned to the subject device)
OAJ
Device Description
The Sialo drain is a flexible, single lumen, sterile, single use, disposable cannula made of biocompatible radio-opaque polyurethane material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
salivary gland, salivary duct
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons
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)
The Sialo Drain device has been subjected to extensive safety, performance, and validation testing before release. Final testing of the SialoTech device included various performance tests designed to ensure that the device met all its functional specifications. Tests have been performed to ensure the device complies with industry and safety standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4200 Introduction/drainage catheter and accessories.
(a)
Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
Sialo Drain 510(k)
pg 1 of 2
510(K) SUMMARY
SIALOTECH DILATION BALLOON KIT AND ACCESSORIES
510(k) Number K072334
JUL 1 8 2008
| Applicant's Name: | Sialo Technologies Ltd.
Suite 220
11 Ben Gurion Boulevard
Ashkelon 78281
Israel
Tel: +972-8-6710795
Fax: +972-9-6782524
e-mail: reuven@sialotechnology.com |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ahava Stein/ Ofer Hornick
A. Stein - Regulatory Affairs Consulting
20 Hata'as St.
Kfar Saba 44425
Israel
Tel. + 972-9-7670002
Fax. +972-9-7668534
e-mail: asteinra@netvision.net.il or oh_asra@netvision.net.il |
| Date Prepared: | August 2007 |
| Trade Name: | Sialo Drain |
| Classification Name: | CFR Classification section 878.4200 (Product code OAJ) |
| Classification: | Class II medical Device |
| Predicate Device: | The Sialo Drain device is comparable to the following predicate devices: |
| | - The Tal MicroDrainage Set manufactured by Boston Scientific Corp. (510k exempt). |
| | - The Drainage Catheters manufactured by Cook Inc. (510k exempt) |
| | - The Jacobs Frontal Sinus Cannula manufactured by Hood Laboratories (510k exempt). |
| | - The Jackson Lachrymal Intubation Set manufactured by Accutome (510k exempt). |
Delia
1
- The Lachrymal Jones Tube manufactured by Gunther Weiss -Scientific Glassblowing co. (510k exempt).
- Device Description: The Sialo drain is a flexible, single lumen, sterile, single use, disposable cannula made of biocompatible radio-opaque polyurethane material.
Intended Use /
Indication for Use:
The Sialo Drain is a medical device for use by qualificd surgeons in the treatment of salivary gland diseases for the purpose of drainage.
The Sialo Drain is an intraoral/extraoral drainage catheter, intended to allow continuous drainage of saliva and/or fluid irrigation of the salivary duct by temporary insertion into the salivary gland, whether orally or through the cheek.
Performance Standards: None.
The Sialo Drain device has been subjected to extensive safety, Test Data: performance, and validation testing before release. Final testing of the SialoTech device included various performance tests designed to ensure that the device met all its functional specifications. Tests have been performed to ensure the device complies with industry and safety standards.
- Substantial The Sialo Drain device is similar to other drains which are put in Equivalence: many body orifices and wounds after surgical procedures, similar to the Sialo Drain.
- The conclusions drawn from the above Performance Testing and Conclusions: comparison to predicate devices, is that the Sialo Drain device is substantially equivalent in safety and efficacy to the predicate devices listed above.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is an abstract symbol resembling an eagle or bird in flight, composed of several curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sialo Technologies, Ltd. % Stein Regulatory Affairs Consulting Ms. Ahava Stein Beit Hapa'amon (Box 124) 20 Hata'as St. 44425 Kfar Saba ISRAEL
JUL 1 8 2008
Re: K072334
Trade/Device Name: Sialo Drain Regulation Number: 21 CFR 878.4200 Regulation Name: Introduction/drainage catheter and accessories Regulatory Class: I Product Code: OAJ Dated: June 30, 2008 Received: July 2, 2008
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.
3
Page 2 - Ms. Ahava Stein
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.
Mark M. Mulkison
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Sialo Drain 510(k)
pg 1 of 1
INDICATIONS FOR USE
510(k) Number (if known): K072334
Device Name: Sialo Drain
Intended Use Statement:
The Sialo Drain is a medical device for use by qualified surgeons in the treatment of salivary gland diseases for the purpose of drainage.
The Sialo Drain is an intraoral/extraoral drainage catheter, intended to allow continuous drainage of saliva and/or fluid irrigation of the salivary duct by temporary insertion into the salivary gland, whether orally or through the cheek.
Prescription Use (Per 21 C.F.R. 801 Subpart D) C)
OR
Over-The-Counter Use (Optional Format Subpart
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
_
(Division Star Off
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number /