(72 days)
Not Found
No
The description focuses on the mechanical function of tubing sets for irrigation and aspiration, with no mention of AI or ML technologies.
No.
The device is described as irrigation and aspiration tubing sets used to flush and instill fluids and remove fluids or debris during surgery to maintain visibility for the operating team. It does not appear to treat or mitigate a disease or condition.
No
The device is described as irrigation and aspiration tubing sets used to flush and instill fluids or remove fluids, air, or debris during surgery to maintain visibility. Its function is to assist in surgical procedures, not to diagnose a medical condition.
No
The device description clearly describes physical tubing sets with spikes, luer locks, wyes, pinch clamps, and valves, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "flush and instill fluids into sites so that visibility is maintained for the operating team" and for "the removal of fluids, air or debris left I fie aspiration the surgery." This describes a device used during a surgical procedure to manage fluids and visibility within the body.
- Device Description: The description details tubing sets, spikes, luer locks, valves, and connectors for attaching to irrigation and suction systems. These are components for delivering and removing fluids from a surgical site.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided description does not mention any testing of samples or analysis of biological material.
- Predicate Device: The predicate device, K923201 EndoSI Suction/Irrigator, is also a surgical device used for suction and irrigation during procedures, not an IVD.
The device described is a surgical accessory used for fluid management during surgery, which falls under a different regulatory classification than IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KDH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 biocompatibility of the device has been tested as part of the Suction Irrigators and has passed.
The tubing sets have been tested to be biocompatible.
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
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.
1
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:
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.
See Addendum V and Addendum VI for the Irrigation Set drawings.
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.
See Addendum VII for the Aspiration Set drawings.
2
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.
3
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:
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.
(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)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)