(109 days)
The ZZIREN™ Orogastric Tube is indicated for use in gastric and bariatric surgical procedures for gastric aspiration and lavage, to serve as a size guide, and to test for leaks.
The ZZIREN™ Orogastric Tube is a non-sterile, single use device comprising a 37-inch-long insertion tube, a Y extension containing a suction regulating valve, and a pinch clamp. An accessory straight connector is included. The insertion is made of flexible polyvinylchloride (PVC). The suction requlating valve limits negative pressure applied to the stomach or intestine to less than 175 mmHg, produces an audible signal when the suction pressure exceeds ~160 mmHg, and is identical in all models. All six models have multiple apertures in proximity to a rounded distal tip. Three of the models, ZZ-SGT-36, ZZ-SGT-40 have side-holes extending 13 cm from the tip, and three models, ZZ-GBT-36, and ZZ-GBT-40, have side-holes extending 6 cm from the tip. The insertion tubes have diameters of 32, 36, and 40 Fr and humeric markings to indicate depth of insertion.
The provided text is a 510(k) summary for the ZZIREN™ Orogastric Tube. It describes a medical device and its substantial equivalence to predicate devices. However, it does not contain any information about a study proving the device meets specific acceptance criteria in the context of device performance related to a diagnostic AI/ML algorithm or similar technology.
The document primarily focuses on:
- Device Description: Physical characteristics and components of the ZZIREN™ Orogastric Tube.
- Intended Use/Indications for Use: What the device is used for (gastric aspiration and lavage, size guide, leak testing in gastric/bariatric surgery).
- Technological Comparison: How the ZZIREN™ Orogastric Tube is similar to and differs from its predicate devices in terms of materials, design features (Y extension, FR sizes, number of apertures), and suction regulating mechanisms.
- Non-Clinical Tests Summary & Conclusions: Results from bench tests (e.g., kink test, stiffness test, compression test, pinch clamp test, connector tests, air syringe compatibility test, dimensional analysis). These tests aim to demonstrate that the new device performs similarly and safely compared to the predicate, and meets its design specifications.
Therefore, I cannot fulfill your request for information about acceptance criteria and a study proving device performance in the context you've provided (which implies a diagnostic or AI-driven device with performance metrics like sensitivity, specificity, or AUC). The document is about a mechanical, single-use surgical accessory, and its "performance" is assessed through physical and functional bench tests, not clinical performance or diagnostic accuracy.
To directly answer your numbered points based on the provided text, where applicable, and noting where the information is absent:
-
A table of acceptance criteria and the reported device performance:
The document describes non-clinical tests and their conclusions, which implicitly serve as performance demonstrations against internal acceptance criteria (e.g., "equally or less stiff," "substantially equivalent," "fit and function well"). However, a formal table of acceptance criteria with quantitative thresholds is not explicitly provided. The conclusions are qualitative comparisons to the predicate devices.Acceptance Criteria (Inferred from Test Goals) Reported Device Performance (Summary) Propensity to kink Substantially equivalent to predicate SIREN SGT™ Stiffness Equally or less stiff than corresponding predicate device Inadvertent stapling likelihood Equally or less likely to be inadvertently stapled than corresponding predicate device Pinch Clamp performance Substantially equivalent to predicate SIREN SGT™ Accessory tubing connector fit and function Attach easily, reversibly, securely; provide reliable connection Compatibility with leak testing device (Air Syringe) Compatible and may be safely used together for leak testing Adherence to design specifications All models made to design specifications -
Sample size used for the test set and the data provenance:
This information is not provided in the document. The tests described are bench tests on the device itself, not clinical studies on patient data. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the document describes bench testing of a physical device, not an AI/ML or diagnostic device requiring expert interpretation for ground truth. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for the same reason as point 3. -
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:
This information is not applicable as the document describes a physical medical device, not an AI/ML or imaging interpretation device. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the document describes a physical medical device. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the bench tests would be the established physical properties and functional requirements of the predicate devices or engineering specifications. For example, the "truth" for the kink test is whether the tube kinks or not under certain conditions, compared to the predicate. There is no biological or diagnostic ground truth mentioned. -
The sample size for the training set:
This information is not applicable as the document describes a physical medical device, not an AI/ML device that requires a training set. -
How the ground truth for the training set was established:
This information is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 10, 2025
Tools for Surgery, LLC Arnold Leiboff President 8 Technology Drive, #100 East Setauket, New York 11733
Re: K242901
Trade/Device Name: ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIRENTM SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32): ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36): ZZIRENTM GBT Orogastric Tube - 40 Fr (ZZ-GBT-40) Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube And Accessories Regulatory Class: Class II Product Code: KNT Dated: September 23, 2024 Received: December 11, 2024
Dear Arnold Leiboff:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory
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assistance/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,
Image /page/2/Picture/3 description: The image shows the name "Anthony Lee -S" in a large, bold, sans-serif font. The text is black against a white background. The letters are evenly spaced and easy to read.
Anthony Lee, 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
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
| Submission Number (if known) | |
|---|---|
| ------------------------------ | -- |
| Device Name |
|---|
| ZZIREN™ Orogastric Tube; |
| ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); |
| ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); |
| ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); |
| ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); |
| ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); |
| ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40) |
Indications for Use (Describe)
The ZZIREN™ Orogastric Tube is indicated for use in gastric and bariatric surgical procedures for gastric aspiration and lavage, to serve as a size guide, and to test for leaks.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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| 510(k) #: K242901 | 510(k) Summary | Prepared on: 2025-01-06 | ||
|---|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | |||
| Applicant Name | Tools for Surgery, LLC | |||
| Applicant Address | 8 Technology Drive, #100 East Setauket NY 11733 United States | |||
| Applicant Contact Telephone | (631)745-2179 | |||
| Applicant Contact | Dr. Arnold Leiboff | |||
| Applicant Contact Email | aleiboff(@toolsforsurgery.com | |||
| Device Name | 21 CFR 807.92(a)(2) | |||
| Device Trade Name | ZZIREN™ Orogastric Tube;ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32);ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36);ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40);ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32);ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36);ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40) | |||
| Common Name | Gastrointestinal tube and accessories | |||
| Classification Name | Tubes, Gastrointestinal (And Accessories) | |||
| Requlation Number | 876.5980 | |||
| Product Code(s) | KNT | |||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | ||
| K220218 | SIREN SGT ™ | KNT | ||
| K234145 | Boehringer Laboratories ViSiGi® 3D | KNT | ||
| Device Description Summary21 CFR 807.92(a)(4) | ||||
| The ZZIREN™ Orogastric Tube is a non-sterile, single use device comprising a 37-inch-long insertion tube, a Y extension containing asuction regulating valve, and a pinch clamp. An accessory straight connector is included. The insertion is made offlexible polyvinylchloride (PVC). The suction requlating valve limits negative pressure applied to the stomach or intestine to less than175 mmHg, produces an audible signal when the suction pressure exceeds ~160 mmHg, and is identical in all models. All six modelshave multiple apertures in proximity to a rounded distal tip. Three of the models, ZZ-SGT-36, ZZ-SGT-40 have side-holesextending 13 cm from the tip, and three models, ZZ-GBT-36, and ZZ-GBT-40, have side-holes extending 6 cm from the tip.The insertion tubes have diameters of 32, 36, and 40 Fr and humeric markings to indicate depth of insertion. | ||||
| Intended Use/Indications for Use21 CFR 807.92(a)(5) |
The ZZIREN™ Orogastric Tube is indicated for use in gastric and bariatric surgical procedures for gastric aspiration and lavage, to serve as a size guide, and to test for leaks.
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Indications for Use Comparison
21 CFR 807.92(a)(5)
The ZZIREN™ Orogastric Tube is indicated for use in gastric surgical procedures for gastric aspiration and lavage, to serve as a sizing guide, and to test for leaks. The Inclusion of "to test for ZZIREN™ Orogastric Tube differs from the indication stated for the primary predicate device in Submission K220218. "To test for leaks" is included in the indications for use of the secondary reference ViSiGi® 3D, which was cleared per Special 510(k) K234145. Use of ZZREN™ Orogastric Tube for leak testing allows the surgeon to more efficiently assess staple line integrity intraoperatively and does not impact the procedures overall safety and effectiveness or the intended use of the device to assist in completion of gastric and bariatric surgery.
Technological Comparison
The proposed Tools for Surgery™ ZZIREN™ Orogastric Tubes, models ZZ-SGT-30, ZZ-GBT-32, ZZ-GBT-36, and ZZ-GBT-40 have technical characteristics similar to that of the primary predicate device, Tools for Surgery™ SIREN SGT™ gastrointestinal tube. All devices are orogastric tubes comprised of biocompatible elastomeric materials.
The proposed devices differ from the predicate device, SIREN SGT™ model SGT-36, by having a Y extension in place of three separate parts (Y connector, extension tube, and suction connector), by having the additional insertion tube calibers of 32 and 40 Fr, and by having 32, 48, 72, or 108 distal apertures (side-holes) instead of the 18 or 36 distal apertures specified in the predicate's 510(k) submission (K220218). (The ViSiGi 3Dº model 5236 [510(k) no. K130483], the antecedent predicate device for K220218, has 108 side holes.)
The Y extension is a single, integral, molded unit having a forward stem to join with the insertion tube, a first arm to contain the suction regulating valve, and a second arm having a segment around which the pinch clamp is disposed, and a rearward expansion to receive a straight connector accessory that is attachable to medical suction tubing. All proposed models have similar Y extensions but different insertion tube calibers or number of apertures. All models employ the same pirmary predicate device to interrupt suction. All models, proposed and precical index markings to help the surgeon and anesthesiologist gauge the depth of insertion and the position of the tube within the upper gastrointestinal tract.
All models, proposed and predicate, connect to a vacuum source in order to deliver neqative pressure to the gastion pressure delivered by the vacuum source is adjustable by means of an external vacuum source suction regulator. All models, proposed and primary predicate, incorporate an identical integral suction regulating valve, which serves as additional means for limiting negative pressure applied to the gastric mucosa. This is a pressure relief valve, which opens at 103 to 155 mm Hg and limits the pressure in the insertion tube and stomach to less than negative 175 mm Hq when full suction (~360 mm Hq) is applied. When negative pressure within the insertion tube of any model, proposed or primary predicate, exceeds 160 mm Hg an audible signal produced by mechanical means by the suction regulating valve informs the operator that excessive suction is being applied, and prompts the operator to lower the suction pressure by manually adjusting the vacuum source suction regulator.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The stiffness, compressibility, and propensity to kink of the insertion tubes of the proposed device are compared to the those the primary and secondary predicates. The pinction of the proposed device is compared to the function of the same part on the primary predicate. Accessory tubing connectors are shown to fit and function well. The proposed device is shown to be compatible with a device for leak testing.
The INSERTION TUBE KINK TEST data shows that the six models of the proposed ZZIREN™Orogastric Tube are substantially equivalent in their propensity to kink to the predicate SIREN SGT™ and are therefore as unlikely to interfere with gastric decompression, lavage, and stapling. The INSERTION TUBE STIFFNESS TEST shows that all models of the proposed device are equally or less stiff than the insertion tubes of their corresponding predicate device and are therefore equally or less likely to cause visceral injury. The INSERTION TUBE COMPRESSION TEST shows that all models of the proposed device are equally or less likely to be inadvertently stapled during gastric surgery than the corresponding predicate device. The PINCH CLAMP TEST shows that the performance of the PINCH CLAMP on the proposed ZZIREN™ Orogastric Tube is substantially equivalent to its performance on the predicate SIREN SGT™. The CONNECTOR TESTS show that both accessory straight tubing connectors attach to the proposed device easily and reversibly in a secure manner and provide a reliable connection to medical suction tubing. The AlR SYRINGE COMPATIBILITY TEST shows that the pariativ Air Syringe are compatible and may be safely used together for leak testing. Dimensional Analysis Tests of all models of the proposed ZZIREN™ device show that all models are made to design specifications.
21 CFR 807.92(a)(6)
§ 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.