ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM
K042018 · Simply Clean Air & Water, Inc. · FIP · Apr 15, 2005 · Gastroenterology, Urology
Device Facts
Record ID
K042018
Device Name
ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM
Applicant
Simply Clean Air & Water, Inc.
Product Code
FIP · Gastroenterology, Urology
Decision Date
Apr 15, 2005
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.5665
Device Class
Class 2
Indications for Use
Systems are intended for use with a hemodialysis system to remove organic and inorganic substances contaminants from water used to dilute dialysis concentrate to form dialysate, reprocessing of hemodialyzers, equipment rinse and disinfection. The Acute PEDI System consists of a sediment filter, carbon filtration, mixed bed deionizers, system monitoring with remote alarm functions. It is intended for use in a location with a portable dialysis machine for the dialysis of a single patient. The Central PEDI System consists of a booster pump / pressure tank assembly, sediment filter, carbon filtration, mixed bed deionizers, resin trap filter, endotoxin filter and system monitoring with flow isolation/divert and remote alarm functions. It is intended for use in a central location for the dialysis of multiple patients. The Back-up PEDI System consists of mixed bed deionizers, intermediate water quality (QC) indicator (light) and connection hoses. It is intended for use to provide a "back-up" for the product outlet of a RO to meet AAMI RD62:2001 requirements. Flow isolation / divert and remote alarm functions are provided when required to meet ANSI/AAMI RD62:2001 requirements.
Device Story
PEDI systems provide purified water for hemodialysis applications per ANSI/AAMI RD62:2001. Input: facility water supply. Transformation: sequential filtration through sediment filters (10-micron polypropylene), granular activated carbon, mixed-bed ion exchange resin, resin trap filters (5-micron), and endotoxin filters. Central system includes booster pump/pressure tank (up to 80 psig). Output: purified water for dialysate. Monitoring: resistivity monitor with digital readout, alarm setpoints, and automated flow isolation/divert valves (except on acute/back-up configurations). Used in clinical settings (acute, central, or back-up) by healthcare staff. Benefits: ensures water quality meets dialysis standards, reducing risk of contaminants in dialysate.
Clinical Evidence
Bench testing only. No clinical data provided. System performance validated against ANSI/AAMI RD62:2001 requirements for water purification in hemodialysis.
Indicated for use with hemodialysis systems to purify water for dialysate preparation, hemodialyzer reprocessing, and equipment disinfection. Acute PEDI for single-patient portable dialysis; Central PEDI for multi-patient central dialysis; Back-up PEDI as a secondary water treatment source.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
US Filter Corporation water treatment systems for dialysis (K980182)
Submission Summary (Full Text)
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APR 1 5 2005
KO42018 1 :F 2 PAGE 000009
### 510(k) Summary
This 510(k) Summary is provided as part of this Premarket Notification to comply with the I mis J10(k) Summary is provided in part of this of 1990 requiring that either a summary be included in a provision or a statement that a summary is available upon request.
Submitter Raymond Kowalec Simply Clean Air & Water FDA Establishment No. 3004114902 28 Shepard Drive P.O. Box 310962 Newington, CT 06131-0962 Tel: (860) 231-0687 Fax:(860) 231-1425 March 4, 2005
Device Names Acute Portable Exchange Deionization (PEDI) System Central PEDI System Back-up PEDI System
Common or usual Name Connization system with pre & post treatment and water distribution components.
Classification Name Water purification systems for hemodialysis (21CFR 876.5665)
## Predicate Device
The Simply Clean Air & Water PEDI Systems are substantially equivalent to US Filter Corporation's (K980182) predicate marketed water treatment systems for dialysis which use carbon and deionization canisters with pre and post filtration to purify water for hemodialysis.
#### Device Description
The PEDI systems are primary or temporary devices to provide water for hemodialysis applications per the requirements of ANSI/AAMI RD62:2001 .
The systems consist of a booster pump / pressure tank assembly, sediment filter, carbon filtration, mixed bed deionizers, resin trap filter, endotoxin filter and system monitoring with flow isolation/divert and remote alarm functions. Refer to Operating Manuals for flow diagrams.
The booster pump / pressure tank assembly (central system only) consists of a multistage pump, The 000ster punp / pressure with. The multistage pump construction has minimum 304 SST wetted
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KCA-2C:8
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parts with no copper or iron wetted parts. The pressure (bladder) tank construction is an airtight shell patis with no copper of non world parks. Subtragm to separate water from tark inside of coul folled steel with a 1 27 upploved battle tax proved starsing 115V/1P/60Hz power to operate a multistage pump to raise pressure up to 80 psig.
The sediment filter consists of a polypropylene housing with pressure relief valve and a replaceable I he scumical the filter cartridge consists of spun polypropylene fiber wound on a polypropylene core and with a filtration rating of 10 microns. (Back-up system uses existing sediment filtration).
The carbon filtration consists of ABS lined fiberglass pressure tank containing granular activated carbon and PVC distributors. The size and number of tanks is dependent on flowrate required with carbon and I VC dictricated in Appendix C. Back-up system uses facilities existing carbon filters if available, Acute system single tank.
The mixed bed deionizers consist of ABS lined fiberglass pressure tank with PVC distributors containing mixed bed ion exchange resin. The size and number of tanks is dependent on flowrate required and inlet water conductivity maximum values listed in Operating Manual.
The resin trap filter consists of a polypropylene housing with pressure relief valve and a replaceable filter cartridge. The filter cartridge consists of spun polypropylene fiber wound on a polypropylene core and has a filtration rating of 5 microns. (Not used on acute systems).
The endotoxin filter consists of a polypropylene housing with a replaceable filter cartridge. The filter cartridge consists of an element with 222 o-ring/closed type seals and has a reduction factor of 10' for bacteria and 10 for endotoxins.
System monitoring consists of pressure gauges, quality control indicator and resistivity monitor. Pressure gauges prior to deionization minimum brass body with phosphorous bellows, gauge after deionization 304 SST stem with SST bellows. The resistivity monitor has a digital readout, indicators for above and below water quality, push buttons for alarm setpoint indication and alarm function test. Connections to the monitor provide under low water quality: remote alarm (horn), isolation of flow to use (valve) and diversion of flow to drain (valve). Inline sensor construction stainless element with polypropylene body. Divert to drain not supplied for acute systems located in patient room. Monitor and divert to drain not supplied for back-up systems with existing monitor/alarm/divert. Refer to Operating Manuals for Control Diagram.
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APR 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Raymond Kowalec Simply Clean Air & Water 28 Shepard Drive P.O. Box 310962 NEWINGTON CT 06131-0962
Re: K042018
Trade/Device Name: Acute PEDI System, Central PEDI System, and Back-up PEDI System Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: March 4, 2005 Received: March 22, 2005
Dear Mr. Kowalec:
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.
If 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 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 (21 CFR Part 801); 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and in yourse FDA finding of substantial equivalence of your device to a legally prematication: " The PDF missification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acrree for your and of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 001:37). " Ou may overnment and Consumer Assistance at its toll-free number (800) DV liston or other Manazactares ins Internet address http://www.fda.gov/cdrh/dsmamain.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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#### Indications for Use
K042018 510(k) Number (if known):
Device Name:
Acute PEDI System Central PEDI System Back-up PEDI System
Indications For Use:
Systems are intended for use with a hemodialysis system to remove organic and inorganic substances Dystelling in contaminants from water used to dilute dialysis concentrate to form dialysate, reprocessing of hemodialyzers, equipment rinse and disinfection.
The Acute PEDI System consists of a sediment filter, carbon filtration, mixed bed deionizers, The route I LL roystem monitoring with remote alarm functions. It is intended for use in a location with a portable dialysis machine for the dialysis of a single patient.
The Central PEDI System consists of a booster pump / pressure tank assembly, sediment filter, I he Contain I Do reystem conson or a resin trap filter, endotoxin filter and system monitoring with Caroon million/divert and remote alarm functions. It is intended for use in a central location for the dialysis of multiple patients.
The Back-up PEDI System consists of mixed bed deionizers, intermediate water quality (QC) indicator (light) and connection hoses. It is intended for use to provide a "back-up" for reverse marcator (tight) and connish" the product outlet of a RO to meet AAMI RD62:2001 requirements. osmobile filtration and system monitoring with flow isolation / divert and remote alarm functions are provided when required to meet ANSI/AAMI RD62:2001 requirements.
Over-The-Counter Use AND/OR X Prescription Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ylance Bradin
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042018
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
