The HPH Junior Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is employed. The device is intended, as is the predicate, for all patients (including all pediatric subgroups) where a small priming volume is desired. In pediatric patients this device must be used only as a part of a cardiopulmonary bypass or circulatory support circuit, with the circuit being connected to the patient.
Device Story
HPH Junior Hemoconcentrator is an ultrafiltration device for cardiopulmonary bypass circuits. Input: patient blood via arterial port. Operation: blood passes through polysulfone hollow fiber bundle within polycarbonate case; hydrostatic pressure gradient across semipermeable membrane drives ultrafiltration. Output: concentrated red cell mass and plasma proteins; removed plasma water and solutes (e.g., IL-6, C3a, C5a) exit via filtrate port. Used in clinical settings (OR/ICU) by perfusionists or physicians. Benefits: reduces excess fluid and inflammatory mediators in patients requiring hemodilution, particularly pediatric patients needing low priming volumes (9ml).
Clinical Evidence
Bench testing only. No clinical data provided. Testing performed per ISO 8637:2004E standards comparing HPH Junior to HPH Mini, covering static prime volume, ultrafiltration performance, blood path pressure drop, protein sieving (albumin, myoglobin, inulin), structural integrity, membrane integrity, and hemolysis.
Technological Characteristics
Polysulfone hollow fiber membrane; polycarbonate housing. Fiber internal diameter: 200 microns. Prime volume: 9ml. Principle: hydrostatic pressure-driven ultrafiltration. Connectivity: standalone component of cardiopulmonary bypass circuit. Sterilization: not specified. Testing standards: ISO 8637:2004E.
Indications for Use
Indicated for all patients, including pediatric subgroups, undergoing cardiopulmonary bypass or circulatory support where acute hemodilution requires fluid removal. Must be used as part of a bypass/circulatory circuit.
Regulatory Classification
Identification
A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.). (3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
Special Controls
*Classification.* Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”
{0}------------------------------------------------
frye ! (2)
K050952
### HPH™ Junior High Performance Hemoconcentrator
510(k) Summary
| Manufacturer: | Minntech Corporation |
|----------------------------|----------------------------------------------------------------------|
| Address: | 14605 28th Ave. N.<br>Minneapolis, MN 55447 |
| Official Contact: | Lynn Lueders<br>Director, Regulatory Affairs<br>Minntech Corporation |
| Device Name: | |
| Trade or Proprietary Name: | HPHTM Junior High Performance<br>Hemoconcentrator |
| Classification Name: | Per 21 CFR 876.5860 High Permeability<br>Hemodialysis System |
| Common Name: | Hemoconcentrator |
Minntech Corporation has supplied the following information to the U.S. Food and Drug Administration to support substantial equivalency of the HPH Junior High Performance Hemoconcentrator to other hemoconcentrators currently on the market in the United States.
#### 1. Device Description:
The HPH Junior Hemoconcentrator consists of many individual polysulfone hollow fibers encapsulated into a polycarbonate case. The device has arterial and venous ports on opposite ends of the device. As the patient's blood enters the device through the arterial blood port, it passes through the fiber bundle and then exits the device through the venous blood port and is returned to the patient. As the blood passes through the fiber bundle, ultrafiltration occurs as a result of a hydrostatic pressure gradient that exists across the semipermeable membrane. The resulting hemoconcentration removes large quantities of plasma water, and small and medium sized solutes (such as IL-6, C3a and C5a) are removed from the vascular space thereby concentrating the red cell mass and the plasma proteins.
#### 2. Intended Use:
The HPH Junior Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is employed. The device is intended, as is the predicate, for all patients (including all pediatric subgroups) where a small priming volume is desired. In pediatric patients this device must be used only as a part of a cardiopulmonary bypass or circulatory support circuit, with the circuit being connected to the patient.
{1}------------------------------------------------
HPH™ Junior High Performance Hemoconcentrator 510(k) Summary Page 2
- Comparison to Another Device in Commercial Distribution Within the United 3. States
The HPH Junior Hemoconcentrator is equivalent in materials and performance to other hemoconcentrators manufactured by Minntech, including the HPH Mini (K980859) High Performance Hemoconcentrator. The only difference between the HPH Junior and the HPH Mini is the diameter of the hollow fibers in the units. The HPH Junior contains fibers that have an internal diameter of 200 microns versus the HPH Mini whose fibers have an internal diameter of 630 microns. This allows the HPH Junior to have a lower prime volume (9ml versus 14ml) than the HPH Mini. The HPH Junior is manufactured using the same materials and manufacturing processes as the predicate device.
This equivalence has been shown though functional and safety testing as required by the relevant FDA guidances and ISO standards including ISO 8637:2004E, Cardiovascular Implants and Artificial Organs - Haemodialysers,
Haemodiafilters, Haemofilters and Haemoconcentrators. This testing, performed on both the HPH Junior and the HPH Mini for comparison purposes included:
- determination of the static prime volume, A.
- ultrafiltration performance, B.
- blood path pressure drop, ز
- protein sieving of albumin, myoglobin, and inulin, D.
- structural integrity E.
- membrane integrity F.
- G. hemolysis
- Summary of Substantial Equivalence 4.
Minntech Corporation has provided information to the U.S. FDA to show that the device is safe and effective when used in accordance to its labeling. This information includes evidence that:
- All materials used in the HPH Junior are currently used in Minntech's a. other HPH family of devices. No new materials or manufacturing methods are used to manufacture this device in comparison to the predicate devices.
- b. As described in Section 3. above. Minntech has performed extensive testing on the device to show that, the performance characteristics of the HPH Junior are substantially equivalent to the predicate device.
{2}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 1 2006
Ms. Lynn Lueders Director, Regulatory Affairs Minntech® Corporation 14605 28th Avenue N. MINNEAPOLIS MN 55447
Re: K050952
Trade/Device Name: HPH™ Junior High Performance Hemoconcentrator Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: December 12, 2005 Received: December 15, 2005
Dear Ms. Lueders:
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 (05) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{3}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
## Indications for Use
510(k) Number (if known): K050952
Device Name:
HPH Junior Hemoconcentrator
Indications for Use:
The HPH™ Junior Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is employed. It is indicated for all patients (including all pediatric patients) according to physician assessment of the patient and the Instructions for Use. In pediatric patients this device must be used only as a part of a cardiopulmonary bypass or circulatory support circuit, with the circuit being connected to the patient.
# (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use L (Per 21 CFR 801.109)
OR
Over-the -counter-use (Optional Format 1-2-96)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K050952
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.
