(259 days)
The MED-TECH Water Systems Inc. Exchangeable Carbon Tanks are intended to be used as a component of a hemodialysis water purification system designed to pretreat and purify potable water for hemodialysis applications. The exchange tanks are intended for use in complete water purification systems employing adequate pretreatment and post-treatment in accordance with current AAMI standards. The exchange tanks are not intended to be used alone. They are intended to remove chlorine and chloramines from water that will be purified by the water purification system and used for hemodialysis applications. Upon exhaustion, these tanks will be replaced with other tanks containing new activated carbon.
MED-TECH Water Systems Inc. Exchangeable Carbon Tanks for Dialysis are Fiberglass Reinforced Polypropylene (FRP) tanks filled with new virgin coal based granular activated carbon (GAC). The carbon media removes chlorine, chloramines, and other organics from the source water through the chemical process of adsorption. Only new virgin coal based granular activated carbon (GAC) of 12X40 mesh size with an iodine number of 1000 or greater is used in the exchange tanks.The tank sizes are range from 6" x 18" through 16" x 65" common for the dialysis industry. The Carbon Exchange Tanks are dedicated for carbon only. MED-TECH Water Systems Inc. recommends that tanks be installed in worker/polisher configuration with the first tank providing the primary purification and the second tank serving as a polisher and back-up to the primary purification.
The provided text describes a 510(k) premarket notification for MED-TECH Water Systems Inc.'s Exchangeable Carbon Tanks for Dialysis. This document is a regulatory submission for a medical device and therefore does not contain information about the acceptance criteria or a study proving device performance in the context of an AI/ML powered device.
The document focuses on demonstrating substantial equivalence to a previously legally marketed predicate device (K944493 G.E.M. Water Systems REVERSE OSMOSIS SYSTEM) rather than presenting a performance study against specific acceptance criteria for a novel AI/ML algorithm.
Here's why the requested information cannot be extracted from this document:
- Device Type: The device described is physical hardware (carbon tanks) for water purification, not an AI/ML software device.
- Regulatory Pathway: The 510(k) pathway involves demonstrating substantial equivalence, which primarily relies on comparing the new device's technological characteristics and intended use to a predicate device. It typically does not require extensive clinical trials or performance studies with acceptance criteria in the way an AI/ML device would.
- "Nonclinical tests": The document mentions "Nonclinical tests were conducted on product water from a replicated exchange tank configuration. Results verify that the device produces endpoints that comply with current AAMI standards for carbon adsorption." However, it does not provide details of these tests, specific acceptance criteria, sample sizes, or ground truth establishment relevant to an AI/ML context. It broadly states compliance with AAMI standards for carbon adsorption, which are likely physical/chemical performance standards, not diagnostic accuracy metrics.
Therefore, I cannot provide the requested table and study details as they are not present in the provided document.
If you have a document describing an AI/ML device, please provide that, and I will be able to answer your questions.
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Image /page/0/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" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 4, 2016
MED-TECH Water Systems, Inc. Brian C. Kim President 1755 Woolner Avenue, Suite B Fairfield, CA 94533
Re: K153329
Trade/Device Name: MED-TECH Water Systems Inc. Exchangeable Carbon Tanks for Dialysis Regulation Number: 21 CFR§ 876.5665 Regulation Name: Water Purification System for Hemodialysis Regulatory Class: II Product Code: FIP Dated: May 2, 2016 Received: May 6, 2016
Dear Brian C. Kim:
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. 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.
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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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Douglas Silverstein -S 2016.08.04 12:39:35 -04'00'
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo and contact information for MED-TECH H2O. The logo includes a caduceus symbol. The address is listed as 1755 Woolner Ave. suite B, Fairfield, CA 94533. The phone number is (707) 427-1564 and the fax number is (707) 427-1834.
May 2, 2016
Indications for Use
510(k) Number (if known): K153329
MED-TECH Water Systems Inc. Exchangeable Carbon Tanks For Dialysis Device Name:
Indications For Use:
The MED-TECH Water Systems Inc. Exchangeable Carbon Tanks are intended to be used as a component of a hemodialysis water purification system designed to pretreat and purify potable water for hemodialysis applications. The exchange tanks are intended for use in complete water purification systems employing apprivations: "The extreatment in accordance with current AAMI standards. The exchange tanks are accidate problemanent and poss. They are intended to remove chlorine and chloramines from water that will be purified by the water purification system and used for hemodialysis applications. Upon exhaustion, these tanks will be replaced with other tanks containing new activated carbon.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
005-1
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Image /page/3/Picture/0 description: The image shows the logo for MED-TECH H₂O. To the left of the company name is a blue medical symbol. Below the company name is the address 1755 Woolner Ave. suite B, Fairfield, CA 94533. The phone number (707) 427-1564 and fax number (707) 427-1834 are also listed.
510(K) SUMMARY
May 2, 2016
| 510(K) Number: | K153329 |
|---|---|
| Submitter: | MED-TECH Water Systems Inc. |
| Contact: | Brian C. Kim1755 Woolner Ave. suite B • Fairfield , CA 94533Phone: (707) 427-1564 Fax: (707) 427-1834Email: brian@medtechwater.net |
| Proprietary Name: | MED-TECH Water Systems Inc. Exchangeable Carbon Tanks for Dialysis |
| Common Name: | Carbon Exchange Tanks for Dialysis |
| Classification Name: | Tank, Holding, Dialysis and Accessories |
| Classification: | Class II Medical Device under §876.5665Panel: GastroenterologyProduct Code:FIP |
| Equivalent Device: | K944493 G.E.M. Water Systems REVERSE OSMOSIS SYSTEM |
Device Description: MED-TECH Water Systems Inc. Exchangeable Carbon Tanks for Dialysis are Fiberglass Reinforced Polypropylene (FRP) tanks filled with new virgin coal based granular activated carbon (GAC). The carbon media removes chlorine, chloramines, and other organics from the source water through the chemical process of adsorption. Only new virgin coal based granular activated carbon (GAC) of 12X40 mesh size with an iodine number of 1000 or greater is used in the exchange tanks.The tank sizes are range from 6" x 18" through 16" x 65" common for the dialysis industry. The Carbon Exchange Tanks are dedicated for carbon only. MED-TECH Water Systems Inc. recommends that tanks be installed in worker/polisher configuration with the first tank providing the primary purification and the second tank serving as a polisher and back-up to the primary purification.
Indications for Use: The MED-TECH Water Systems Inc. Exchangeable Carbon Tanks are intended to be used as a component of a hemodialysis water purification system designed to pretreat and purify potable water for hemodialysis applications. The exchange tanks are intended for use in complete water purification systems employing adequate pretreatment and post-treatment in accordance with current AAMI standards. The exchange tanks are not intended to be used alone. They are intended to remove chlorine and chloramines from water that will be purified by the water purification system and used for hemodialysis applications. Upon exhaustion, these tanks will be replaced with other tanks containing new activated carbon.
Statement of Substantial Equivalence: The MED-TECH Water Systems Inc. Exchangeable Carbon Tanks are substantially equivalent to the carbon exchange tanks included in G.E.M. Water Systems' REVERSE OSMOSIS SYSTEM (K944493). The MED-TECH design was originally based exclusively on the G.E.M. Water Systems exchange tanks. The following table compares and contrasts the predicate device and the new device. This table along with the documentation included in this submission demonstrates that there are no new issues of safety or effectiveness associated with this design change, and that the new device is substantially equivalent to the predicate device.
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| MED-TECH Water Systems Inc. | G.E.M. Water SystemsK944493 | |
|---|---|---|
| Indications for use | The MED-TECH Water Systems Inc.Exchangeable Carbon Tanks are intended to beused as a component of a hemodialysis waterpurification system designed to pretreat andpurify potable water for hemodialysisapplications. The exchange tanks are intendedfor use in complete water purification systemsemploying adequate pretreatment and post-treatment in accordance with current AAMIstandards. The exchange tanks are not intendedto be used alone. They are intended to removechlorine and chloramines from water that willbe purified by the water purification system andused for hemodialysis applications. Uponexhaustion, these tanks will be replaced withother tanks containing new activated carbon. | The intended use of this device is to purify water tomeet AAMI standards for hemodialysis treatment. |
| Tanks | Park/Structural or Wave Cyber FRP tanks | Park/StructuralFRP tanks |
| Tank Heads / Fill Plug | Clack, Pentair, or American Water ProductsPVC heads, PVC plug | ClackPVC heads, PVC plug |
| Fittings | Glass-filled Noryl | Glass-filled Noryl |
| Distributor | Pentair or ClackPVC distributor | ClackPVC distributor |
| Stand Pipe | PVC | PVC |
| Carbon | Virgin, coal-based, granular activated carbon(GAC) 12X40 mesh iodine number $≥$ 1000 | Virgin, coal-based, granular activated carbon (GAC)12X40 mesh iodine number $≥$ 1000 |
| Principles of operation | Carbon adsorptionGranular activate carbon (GAC) removeschlorine and chloramines from water throughthe process of adsorption. | Carbon adsorptionGranular activate carbon (GAC) removes chlorineand chloramines from water through the process ofadsorption. |
The MED-TECH Water Systems Inc. Exchangeable Carbon Tanks are substantially equivalent to Conclusion: the carbon exchange tanks included in G.E.M. Water Systems' REVERSE OSMOSIS SYSTEM (K944493). All of the components and technology included in this submission are identical to the predicate device and there are no new issues of safety or effectiveness. Nonclinical tests were conducted on product water from a replicated exchange tank configuration. Results verify that the device produces endpoints that comply with current AAMI standards for carbon adsorption.
§ 876.5665 Water purification system for hemodialysis.
(a)
Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.(b)
Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.