The irrigation tubing sets will be used to flush and instill fluids into sites so that visibility is maintained for the operating team. The sets will be attached to standard irrigation systems such as either gravity bag systems attached to I.V. standard neiganian a pump systems that use pressurized bottles instead of the gravity fed bags as the source of the irrigant. The handle or accessory for irrigation would be attached to the end opposite the irrigant source.

The aspiration tubing sets will be used for the removal of fluids, air or debris left I fie aspiration the surgery. These sets could be used just to remove the flushing irrigant that is used to keep the surgical arena visible. One ond would be attached to the suction source and the other end would be attached to the suction tip handle.

Device Description

The irrigation sets will be offered in different sizes with spikes and luer locks for attachments to the gravity bag feed systems. There would be four different size attaching to the grate to allow the customer to chose the most economical set according to what their requirements are. There would be one dual set with a wye and two pinch clamps to allow for the use of two supply bags. There would w one set offered with valves for the use of the bottle type supply systems so that clamps would not have to be activated for operation.

The aspiration tubing sets will be offered in different sizes with suction I no aspreaten and luer locks for those smaller sizes that require them for hooking them to the suction system. The larger sizes may be used by just pushing the tubing over the barbed connectors on the suction supply systems.

AI/ML Overview

This document is a 510(k) Pre-Market Notification for the SuperFlow Irrigation and Aspiration Tubing Sets. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way a clinical study would for a diagnostic or therapeutic device.

The document discusses the device's substantial equivalence to a predicate device (EndoSI Suction/Irrigator), focusing on design, composition, function, and biocompatibility. The "study" mentioned is primarily related to the validation of the sterilization process and biocompatibility testing, not a performance study against acceptance criteria from a clinical or diagnostic perspective.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert involvement, and comparative effectiveness studies is not applicable or cannot be extracted from this particular document.

Here's what can be extracted based on the document's content:

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

Acceptance Criteria Category	Reported Device Performance (as stated in the document)
Substantial Equivalence	"The safety and effectiveness of this device is substantially equivalent to that of the predicate device (The EndoSI Suction Irrigators) because the components are identical to those that have been used in the EndoSI Suction Irrigations."
Biocompatibility	"The tubing sets have been tested to be biocompatible." (Referenced Addendum IX for information)
Sterility Assurance Level (SAL)	"The sterility assurance level will be 10(-6)."
Sterilization Method Validation	"The sterilization process for the EndoSI Suction/Irrigator has been validated utilizing the guidelines issued by AAMI for Method I Radiation Sterilization. This validation will apply to the irrigation and aspiration tubing sets."
Radiation Dose	"Both of the irrigation and aspiration tubing sets will be processed on a production basis at 25 to 35 kGs."

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

Not applicable. This document is a pre-market notification (510(k)) asserting substantial equivalence, not a report on a clinical or performance study that would have a test set for diagnostic accuracy or efficacy. The "testing" mentioned refers to biocompatibility and sterilization validation, not clinical performance. Specific sample sizes for these tests are not provided in the summary.
Data Provenance: Not specified for any underlying biocompatibility or sterilization validation data within this summary.

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. This document does not describe a study involving expert-established ground truth for a test set.

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

Not applicable. There is no "test set" or adjudication process described in this document.

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

Not applicable. This device is a medical accessory (tubing sets) for irrigation and aspiration, not an AI-powered diagnostic or therapeutic device. No MRMC study was conducted or is relevant.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable for clinical performance. The "ground truth" equivalent for this device is compliance with material safety (biocompatibility), manufacturing standards (sterilization validation), and demonstrating physical equivalence and functionality to the predicate device.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable. This is a physical medical device.

Summary

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14981286
5

ARMM, Inc.

17744 Sampson Lane Huntington Beach, CA 92647 714-848-8190 Fax 714-848-6141

Submitter: Roger Wood

Date 04/06/98

2. SMDA Requirements: 510(K) Summary

.Trade name

Classification Name: Gastroenterology-urology devices Proprietary Name: SuperFlow Irrigation and Aspiration Tubing Sets

. Common Name

Common Name: Gastrointestinal tube and accessories

. Device Class

The devices listed in this classification referenced in the Code of Federal Regulations (21 CFR 876.59800) are Class II classification number 78KDH.

. New or Modification

The devices listed in this 510(k) summary are modifications of the existing device called the EndoSI Suction/Irrigator previously approved with the 510(K) #K923201.

The safety and effectiveness of this device is substantially equivalent to that of the predicate device (The EndoSI Suction Irrigators ) because the components are identical to those that have been used in the EndoSI Suction Irrigations. The biocompatibility of the device has been tested as part of the Suction Irrigators and has passed. This device is similar in design, composition and function to the EndoSI Suction Irrigator. The modification done is by removing the suction/irrigation trumpet valve unit from the corresponding tubing sets and selling the tubing sets for aspiration and irrigation by themselves for indications in general and gastrointestinal surgery not just laparoscopic surgeries. The tubing is offered in different sizes. There are no different technological characteristics of this device compared to the suction/irrigator.

The irrigation tubing sets are conduits for irrigant. One end is hooked up to the irrigant source and the other is hooked to a handle or accessory for flushing and washing.

The aspiration tubing sets are conduits for suction. One end is hooked up to the suction source while the other is hooked to a handle oraccessory for the removal of fluids, air and debris.

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3. Proposed Labeling:

a.Package Labels

Sec Addendum I for a copy of the proposed label for the Irrigation Sets. See Addendum II for a copy of the proposed label for the Aspiration Sets.

b. Statement of intended use

Irrigation Tubing Sets: This tubing set is for use with typical bag or bottle irrigation systems. Irrigate as desired. (Refer to the instructions for the irrigation system in use.)

Aspiration Tubing Sets: This tubing set is for use with typical aspiration systems. Aspirate as required. (Refer to the instructions for the aspiration system in use.)

c. Promotional Materials

C. Fromotional Museum III for a copy of the promotional materials for the Irrigation Tubing Sets.

See addendum IV for a draft copy of the promotional material for the Aspiration Tubing Sets.

4. Description of Device:

See Addendum V and Addendum VI for the Irrigation Set drawings.

See Addendum VII for the Aspiration Set drawings.

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5. Comparison Information:

These products are similar in design, composition and function to existing marketed tubing scts. The tubing is identical to what is presently being supplied in the afore mentioned EndoSI suction/irrigation device. The aspiration tubing sets are similar in form and function to the suction tubing used on the EndoSSI Suction Irrigation tubing sets are similar to the irrigation tubing used on the EndoSI Suction Irrigator.

See Addendum VIII for the EndoSI Suction/Irrigator with Tubing Sets compared to the proposed Irrigation Tubing Sets and Aspiration Tubing Sets.

6. Biocompatibility data or certification of identical material /formulation:

a. Component and materials

The components and the matcrials that are being utilized are identical to those that have been used in the EndoSI Suction/Trrigator. The tubing is made from the PVC tubing and all of the components will be either PVC, ABS or acrylic,

b. Patient contacting materials

The patient contacting materials will be the PVC tubing.

c. Biocompatibility

The tubing sets have been tested to be biocompatible. See Addendum IX for the information.

7. Sterilization and expiration dating information:

a. Sterilization Method

Sterilization will be accomplished by Gamma Radiation (Cobalt 60). The sterilization process for the EndoSI Suction/Irrigator has been validated utilizing the guidelines issued by AAMI for Method I Radiation Sterilization.

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This validation will apply to the irrigation and aspiration tubing sets. However, periodic audits will be undertaken for both of these tubing sets to assure the sterility on an ongoing basis.

The manufacturing date will be placed on the label instead of using an expiration date.

b. Sterility Assurance Level

The sterility assurance level will be 10(-6).

c. Packaging

The irrigation tubing sets will be pouched in standard mylar/tyvek pouches with a label placed on the exterior of the pouch. Units will be placed 10 units per box.

The Aspiration Tubing sets will be pouched in standard mylar/tyvek pouches with a label placed on the exterior of the pouch. Units will be placed 10 units per box.

d. Pyrogenicity

No claims on the non-pyrogenicity of the tubing sets will be made.

e. Radiation dose

Both of the irrigation and aspiration tubing sets will be processed on a production basis at 25 to 35 kGs. Periodic audits will be undertaken to assure conformance to applicable standards.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 9 1998

Mr. Roger Wood ·ARMM, Incorporated 17744 Sampson Lane Huntington Beach, California 92647

K981286 Re: SuperFlow Irrigation/Aspiration Tubing Trade Name: Regulatory Class: II Product Code: KDH Dated: April 6, 1998 Received: April 8, 1998

Dear Mr. Wood:

We have reviewed your Section 510(k) notification of intent to market the device referenced above 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.

It 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. V substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 Please note: concerning your device in the Federal Register. 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 requlations.

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Page 2 - Mr. Wood

This letter will allow you to begin marketing your device as This letter will allow you co regin mainer of more to a le described in your 510() prematic not revice to a legally
finding of substantial equivalence of your device for your finding of substancial equivation of yoursed to the market marketed predicate device results in a craceed to the market.
device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling If you desire specific auvice for your mally 809.10 for in
regulation (21 CFR Part 801 and additionally 809.10 for in regulation (21 crk rate over and and the Office of vitro diagnostic devices), piease contact y, for questions on
Compliance at (301) 594-4595. Additionally, for quese contact Compliance at (301) 394-4395. "Address device, please contact
the promotion and advertising of your device, Alease no the promotion and advertising of your develop please note
the Office of Compliance at (301) 594-4639. Also, please note the Office of Complation at (1001) on reference to
the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97) . information on your responsibilities under the Act may be information on your responsibilities and acturers Assistance
obtained from the Division of Small Manufacturers Assistance obtained from the DV1310n of Smart Manazadaan or at
at its toll-free number (800) 638-2041 or (301) 443-6597 or at at its toll-free number (800) 656-2041 0) (302) - 1
its internet address "http://www.tda.gov/cdrh/dsmamain.html".

Sincerely yours,

Colia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): K981286

Dovico Namo: SuperFlow Irrigation and_Aspiration Tubing Sets

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K981286

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.