K962959 · Hdc Medical, Inc. · MED · Jun 5, 1998 · General Hospital
Device Facts
Record ID
K962959
Device Name
PERACIDIN DIALYZER REPROCESSING CONCENTRATE
Applicant
Hdc Medical, Inc.
Product Code
MED · General Hospital
Decision Date
Jun 5, 1998
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.6885
Device Class
Class 2
Indications for Use
Peracidin™ Dialyzer Reprocessing Concentrate is indicated for the in-vitro cleaning and disinfection of hollow fiber dialyzers, classified as follows: Conventional dialyzer, 21 CFR 876.5820, product code 78 FJI High permeability dialyzer, 21 CFR 876.5860, product code 78 KDI The product is intended for use only with reprocessing systems, automated or manual, that have been validated by the system manufacturer for use with peracetic acid. The intended use of Peracidin is identical to that of Renalin.
Device Story
Peracidin Dialyzer Reprocessing Concentrate is a liquid chemical disinfectant used for the in-vitro cleaning and disinfection of hollow fiber dialyzers. The device is a stabilized mixture of hydrogen peroxide (27.0%) and peroxyacetic acid (4.5%). It is used in conjunction with automated or manual dialyzer reprocessing systems that have been validated for peracetic acid. The solution acts as a biocidal agent, providing bactericidal, sporocidal, tuberculocidal, pseudomonacidal, and virucidal activity. Upon use, the concentrate breaks down into acetic acid, water, and oxygen, which have low or no toxicity. The device is intended for use in clinical settings where dialyzer reprocessing is performed.
Clinical Evidence
No clinical data. Efficacy and performance characteristics are based on the established biocidal properties of peroxyacetic acid and extensive long-term clinical use documented in scientific literature.
Technological Characteristics
Stabilized liquid mixture of 27.0% hydrogen peroxide and 4.5% peroxyacetic acid; 68.5% inert ingredients. Clear, colorless, acidic, water-soluble. Functions as a chemical germicide.
Indications for Use
Indicated for in vitro cleaning and disinfection of hollow fiber dialyzers. Intended for use only with automated or manual reprocessing systems validated for peracetic acid.
Regulatory Classification
Identification
A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.
Special Controls
*Classification.* Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.
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JUN 5 1998
510(k) SUMMARY
K962959
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
Submitter's Name: HDC Medical, Inc.
707 Farmingham Road
Louisville, KY 40243 USA
Telephone: (502) 267-7873
Contact Person: Hugh Doss, President
Date of Summary: June 3, 1998
Device Name: Peracidin™ Dialyzer Reprocessing Concentrate
Device Classification: Liquid Chemical Disinfectant (80 MED)
Legally Marketed Device To Which Equivalence Is Claimed: Renalin Cold Sterilant (K882564), manufactured by Minntech Corporation, determined to be substantially equivalent to a pre-enactment device on January 9, 1989.
Device Description: Peracidin™ Dialyzer Reprocessing Concentrate is a stabilized mixture of hydrogen peroxide 27.0% and peroxyacetic acid 4.5%; inert ingredients are 68.5% (nominal concentrations). The concentrate is a clear colorless liquid, is highly acidic, and is completely soluble in water. Peracidin breaks down to acetic acid, water, and oxygen.
Intended Use: Peracidin™ Dialyzer Reprocessing Concentrate is indicated for the in-vitro cleaning and disinfection of hollow fiber dialyzers, classified as follows:
Conventional dialyzer, 21 CFR 876.5820, product code 78 FJI
High permeability dialyzer, 21 CFR 876.5860, product code 78 KDI
The product is intended for use only with reprocessing systems, automated or manual, that have been validated by the system manufacturer for use with peracetic acid. The intended use of Peracidin is identical to that of Renalin.
Descriptive Summary Of Technological Characteristics And Those Of Predicate Device: Both Peracidin and Renalin are stabilized mixtures of hydrogen peroxide and peroxyacetic acid. The products are liquid chemical disinfectants used for reprocessing of hollow fiber dialyzers. The concentrations of hydrogen peroxide and peracetic acid in the two products are identical. The technological characteristics of Renalin and Peracidin are identical.
Performance Data: Peroxyacetic acid (PA), the primary active ingredient in both Renalin and Peracidin, has been shown to be an effective biocidal agent. Peracetic acid-based chemical germicides have a long history of use in dialyzer reprocessing. The actions of these germicides are bactericidal, sporocidal, tuberculocidal, pseudomonacidal, virucidal, and effective against non-tuberculous mycobacteria (NTM). The decomposition products have low or no toxicity. Efficacy and other performance characteristics are well-established by extensive long-term clinical use and are well-documented in the scientific literature. The safety and effectiveness performance of Peracidin are identical to the safety and effectiveness performance of Renalin.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
JUN 5 1998
HDC Medical, Incorporated
C/O Ms. Lisa S. Jones
Regulatory Affairs Consultant
Devices for the Future, L.L.C.
9223 Ilona Lane
Houston, Texas 77025-4218
Re: K962959
Trade Name: Peracidin Dialyzer Reprocessing Concentrate
Regulatory Class: Unclassified
Product Code: MED
Dated: May 5, 1998
Received: May 6, 1998
Dear Ms. Jones:
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 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Ms. Jones
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Division of Dental, Infection Control, and General Hospital Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
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JUN-03-'98 09:00 ID:DEVICES FOR FUTURE TEL NO:713P6646070 #180 P02
June 3, 1998
Page 1 of 1
510(k) Number: K962959
Device Name: Peracidin Dialyzer Reprocessing Concentrate
Indications for Use:
Peracidin Dialyzer Reprocessing Concentrate is indicated for the in vitro cleaning and disinfection of hollow fiber dialyzers. The product is intended for use only with dialyzer reprocessing systems, automated or manual, that have been validated for use with peracetic acid.
(Concurrence of CDRH, Office of Device Evaluation (ODE))
Chris S. Lim
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K962959
Prescription Use ☐
(Per 21 CFR 801.109)
OR
Over-the-Counter Use ☑
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.
