(112 days)
Not Found
No
The device description and performance studies focus on mechanical and pressure-regulating functions, with no mention of AI or ML.
Yes
The device is used in gastric and bariatric surgical procedures for aspiration, lavage, and to assist in gastric sleeve formation, directly impacting a patient's medical condition or body function.
No
The device is indicated for gastric aspiration, lavage, and to assist in gastric sleeve formation by decompressing, stabilizing, and sizing the stomach during surgical procedures. Its function is primarily interventional and supportive during surgery, not to diagnose a condition.
No
The device description clearly outlines physical components made of PVC, a hub, valves, tubes, and markings. The performance studies also focus on the physical properties and function of these hardware components. There is no mention of software as a component or function of the device.
Based on the provided information, the SIREN SGT™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a device used during surgical procedures for gastric aspiration, lavage, and assisting in gastric sleeve formation. This is a direct intervention on the patient's body.
- Device Description: The description details a physical tube with a suction regulating valve and other components designed for insertion into the stomach. This is a medical device used for a physical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples. The SIREN SGT™ is used inside the body during a surgical procedure.
N/A
Intended Use / Indications for Use
The SIREN SGT™ is indicated for use in gastric and bariatric surgical procedures for gastric aspiration and lavage, and to assist in gastric sleeve formation by decompressing and stabilizing the stomach, and by serving as a sizing guide.
Product codes (comma separated list FDA assigned to the subject device)
KNT
Device Description
The Tools for Surgery™ SIREN SGT™ gastric tube is a clean, non-sterile, single patient use device, comprising a 36 Fr insertion tube portion 109 cm long, a hub containing a suction regulating valve, an extension tube, pinch clamp, and connector. Tubular portions including the hub are flexible polyvinylchloride (PVC). There are multiple apertures in proximity to a rounded distal tip. Line and numeric markings are provided to indicate depth of insertion. The suction regulating valve limits negative pressure applied to the stomach to less than 175 mmHg, and produces an audible signal when the suction pressure in the stomach exceeds ≈160 mmHg.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastric
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 following non-clinical test reports have been submitted, referred to, and relied on in this 510(k) submission:
- VALVE FUNCTION TEST
- MAXIMAL NEGATIVE PRESSURE TEST ●
- AUDIBLE SIGNAL TEST ●
- VISIGI PRESSURE COMPARISONS
- DIMENSIONAL ANALYSIS TEST
- INSERTION TUBE KINK TESTS
- INSERTION TUBE COMPRESSION TESTS
- INSERTION TUBE STIFFNESS TEST
- JOINT STRENGTH TEST
- CAP BOND STRENGTH TEST
- CONNECTOR TEST
- . SEAL TEST
- BUBBLE TEST, SGT
- BUBBLE TEST, VISIGI
- PACKAGE INSPECTION TEST
- . COLOR TEXTURE PRINT TEST, AGED
- VALVE FUNTION TEST, AGED
- . MAXIMAL NEGATIVE PRESSURE TEST, AGED
- . TUBE DEGRADATION TEST, AGED
- INSERTION TUBE KINK TEST, AGED
- PINCH CLAMP FUNCTION TEST, AGED
- JOINT STRENGTH TEST, AGED
- CAP BOND STRENGTH TEST, AGED
- THE L929 NEUTRAL RED UPTAKE TEST (1 CONCENTRATION) - ISO
- THE INTRACUTANEOUS INJECTION TEST ISO ●
- THE KLINGMAN MAXIMIZATION TEST ISO ●
The performance tests referenced above substantiate that the proposed device performs equivalently to the predicate device, and validate the function regulating valve and audible signal mechanism.
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.
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
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory 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 (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 18, 2022
Tools for Surgery, LLC Arnold Leiboff, M.D. President 8 Technology Drive, #100 East Setauket, NY 11773-3327
K220218 Trade/Device Name: Siren SGT Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: KNT Dated: April 12, 2022 Received: April 19, 2022
Dear Arnold Leiboff:
Re:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
(21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Je Hi An, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220218
Device Name SIREN SGTTM
Indications for Use (Describe)
The SIREN SGT™ is indicated for use in gastric and bariatric surgical procedures for gastric aspiration and lavage, and to assist in gastric sleeve formation by decompressing and stabilizing the stomach, and by serving as a sizing guide.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| Submitter Name: | Tools for Surgery, LLC |
|---|---|
| Submission Date: | January 24, 2022 |
| Submitter Address: | 8 Technology Drive, #100 |
| East Setauket, NY 11733-3327 | |
| Contact Person: | Arnold R. Leiboff, M.D., President |
| Contact Email: | aleiboff@toolsforsurgery.com |
| Phone Number: | (631) 444-4448 |
| Fax Number: | (631) 444-5330 |
| Prepared By: | Arnold R. Leiboff, MD |
| Date Prepared: | January 19, 2022 |
| Device Trade Name: | SIREN SGTTM |
| Device Common Name: | Gastrointestinal Tube and Accessories |
| Device Product Code: | KNT |
| Regulation: | 876.5980 |
| Device Class: | Class II |
| Classification Panel: | Gastroenterology and Urology |
| Classification Name: | Gastrointestinal Tube and Accessories |
| Predicate Device: | Boehringer Laboratories Gastric Sizing Tube (ViSiGi 3D®) |
| 510(k) Number: K130483 | |
| Device Description: | The Tools for Surgery™ SIREN SGTTM gastric tube is a clean, non- |
| sterile, single patient use device, comprising a 36 Fr insertion tube | |
| portion 109 cm long, a hub containing a suction regulating valve, an | |
| extension tube, pinch clamp, and connector. Tubular portions | |
| including the hub are flexible polyvinylchloride (PVC). There are | |
| multiple apertures in proximity to a rounded distal tip. Line and | |
| numeric markings are provided to indicate depth of insertion. The | |
| suction regulating valve limits negative pressure applied to the | |
| stomach to less than 175 mmHg, and produces an audible signal when | |
| the suction pressure in the stomach exceeds ≈160 mmHg. | |
| Indications for Use: | The SIREN SGTTM is indicated for use in gastric and bariatric |
| surgical procedures for gastric aspiration and lavage, and to assist in | |
| gastric sleeve formation by decompressing and stabilizing the | |
| stomach, and by serving as a sizing guide. |
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Substantial Equivalence Comparison
Table 1
| Table 1 | |||
|---|---|---|---|
| Device | Proposed Device | ||
| SIREN SGTTM | Predicate Device | ||
| ViSiGi 3D® | Comparison | ||
| Manufacturer | Tools for Surgery, LLC | Boehringer Laboratories, LLC | |
| Model (Catalog No.) | SGT-36 | 5236 | |
| Intended Use | |||
| Indication for Use | |||
| Statement | The Tools for Surgery™ SIREN | ||
| SGTTM is indicated for use in gastric | |||
| and bariatric surgical procedures for | |||
| gastric aspiration and lavage, and to | |||
| assist in gastric sleeve formation by | |||
| decompressing and stabilizing the | |||
| stomach, and by serving as a sizing | |||
| guide. | The Boehringer Laboratories | ||
| ViSiGi 3D® is indicated for use in | |||
| gastric and bariatric surgical | |||
| procedures for the application of | |||
| suction, stomach decompression, | |||
| drainage of gastric fluids, | |||
| irrigation and to serve as a sizing | |||
| guide. | Same | ||
| Typical Use | Gastric and bariatric procedures | Gastric and bariatric procedures | Same |
| Environments of Use | Surgery centers, hospitals | Surgery centers, hospitals | Same |
| Patient Population | Individuals undergoing bariatric | ||
| and/or gastric procedures | Individuals undergoing bariatric | ||
| and/or gastric procedures | Same | ||
| Intraoperative Use | Yes | Yes | Same |
| Functions | Suction, decompression, drainage, | ||
| irrigation, sizing | Suction, decompression, drainage, | ||
| irrigation, sizing | Same | ||
| Technical/Performance Characteristics | |||
| Insertion Tube | Single lumen with rounded, closed | ||
| distal end | Single lumen with rounded, closed | ||
| distal end | Same | ||
| Insertion Tube Length | 109 cm | 107 cm | Same |
| Outer Diameter | 36 Fr | 36 Fr | Same |
| Distal Side Holes | 18 or 36 apertures | 108 apertures | Different |
| Internal Support of Distal | |||
| Portion | No | Stainless steel coil | Different |
| Connector for Suction | Yes | Yes | Same |
| Suction Regulating Valve | Pressure relief valve | Inline shut-off valve | Different |
| Valve Actuating Pressure | |||
| (Manufacture's | |||
| specification) | 129 mmHg ± 26 mmHg | 125 mmHg ± 25 mmHg | Similar |
| Audible Pressure Signal | Yes | No | Different |
| Manual Suction Valve | Pinch Clamp | Selection (Slide) Valve | Different |
| Insertion Tube Material | DEHP-free PVC | SEBS Co-polymer | Different |
| Line Markings to Guide | |||
| Insertion Depth | Yes | Yes | Same |
| Numeric Markings to Guide | |||
| Insertion Depth | Yes | No | Different |
| Sterility | Supplied non-sterile | Supplied non-sterile | Same |
| Single Use, Disposable | Yes | Yes | Same |
5
Performance/Non-Clinical Testing
The following non-clinical test reports have been submitted, referred to, and relied on in this 510(k) submission:
- VALVE FUNCTION TEST
- MAXIMAL NEGATIVE PRESSURE TEST ●
- AUDIBLE SIGNAL TEST ●
- VISIGI PRESSURE COMPARISONS
- DIMENSIONAL ANALYSIS TEST
- INSERTION TUBE KINK TESTS
- INSERTION TUBE COMPRESSION TESTS
- INSERTION TUBE STIFFNESS TEST
- JOINT STRENGTH TEST
- CAP BOND STRENGTH TEST
- CONNECTOR TEST
- . SEAL TEST
- BUBBLE TEST, SGT
- BUBBLE TEST, VISIGI
- PACKAGE INSPECTION TEST
- . COLOR TEXTURE PRINT TEST, AGED
- VALVE FUNTION TEST, AGED
- . MAXIMAL NEGATIVE PRESSURE TEST, AGED
- . TUBE DEGRADATION TEST, AGED
- INSERTION TUBE KINK TEST, AGED
- PINCH CLAMP FUNCTION TEST, AGED
- JOINT STRENGTH TEST, AGED
- CAP BOND STRENGTH TEST, AGED
- THE L929 NEUTRAL RED UPTAKE TEST (1 CONCENTRATION) - ISO
- THE INTRACUTANEOUS INJECTION TEST ISO ●
- THE KLINGMAN MAXIMIZATION TEST ISO ●
Discussion
The Tools for Surgery™ SIREN SGT™ gastric tube is similar to the predicate device Boehringer Laboratories Gastric Sizing Tube (ViSiGi 3D®).
Intended Use
The indications for use of the Tools for Surgery™ SIREN SGT™ and the Boehringer Laboratories ViSiGi 3D® are the same.
Technical Characteristics
The Tools for Surgery™ SIREN SGT™ gastric tube has technical characteristics similar to that of the predicate device. Both devices are orogastric tubes comprised of biocompatible elastomeric materials. The predicate device incorporates a slide valve to interrupt suction, while
6
the SIREN SGT™ employs a pinch clamp for this purpose. The insertion tubes of both devices have interval markings to help the surgeon and anesthesiologist gauge the depth of insertion and the position of the tip of the tube. The markings on the predicate device are simple lines that are indistinguishable from one another, while the markings on the SIREN SGT™ include numeric figures that indicate the exact distance to the forward tip of the insertion tube. The predicate device includes an internal metal coil support to stiffen the distal portion of its insertion tube; the SIREN SGT™ does not. The SIREN SGT™ insertion tube comprises one or two rows of 18 apertures, whereas the predicate device, ViSiGi 3D®, comprises six rows of 18 apertures. Both the SIREN SGT™ and predicate device connect to a vacuum source in order to deliver negative pressure to the gastric lumen. The suction pressure delivered by the vacuum source is adjustable by means of an external vacuum source suction regulator. Both the SIREN SGT™ and the predicate device incorporate integral suction regulating valves, which serve as additional means for limiting negative pressure applied to the gastric mucosa. The predicate device achieves this by means of an inline shut-off valve, which closes when negative pressure exceeds 100-150 mmHg. The SIREN SGT™ contains a pressure relief valve, which opens at 103 to 155 mmHg and limits the pressure in the insertion tube and stomach to negative 175 mmHg when full suction (~360 mmHg) is applied. When negative pressure within the SIREN SGT™ insertion tube exceeds 160 mmHg an audible signal produced by mechanical means by the suction regulating valve informs the operator that excessive suction is being applied to the tube, and prompts the operator to lower the suction pressure by manually adjusting the vacuum source suction regulator.
Performance Testing
The performance tests referenced above substantiate that the proposed device performs equivalently to the predicate device, and validate the function regulating valve and audible signal mechanism.
Conclusion
As evidenced by the intended use, technical characteristics, and performance testing, the Tools for Surgery™ SIREN SGT™ gastric tube is substantially equivalent to the predicate device.