DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329
Applicant
Datascope Corp.
Product Code
DSP · Cardiovascular
Decision Date
Mar 13, 2000
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 870.3535
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations: · Refractory ventricular failure · Cardiogenic shock · Unstable refractory angina · Impending infarction Mechanical complications due to acute myocardial infarction . · Ischemic related intractable ventricular arrhythmias · Cardiac support for high risk surgical patients and coronary angiography or angioplasty patients · Septic shock · Weaning from cardiopulmonary bypass · Interoperative pulsatile flow generation · Support for failed angioplasty and valvuloplasty
Device Story
Intra-aortic balloon (IAB) catheter; 8Fr polyimide construction; 25cc, 34cc, 40cc volumes. Placed in descending aorta; provides mechanical circulatory support. Used in clinical settings (OR/ICU) by physicians to improve cardiovascular function via counterpulsation. Device assists heart by reducing afterload and increasing coronary perfusion. Benefits include hemodynamic stabilization in shock or high-risk surgical/interventional contexts.
Clinical Evidence
No clinical evaluations performed. Substantial equivalence supported by in-vitro bench testing comparing functionality and performance characteristics to predicate devices.
Technological Characteristics
8Fr polyimide IAB catheter; 25cc, 34cc, 40cc volumes. Mechanical circulatory support device. Differs from predicates in material grade and chemical composition. No software or electronic components.
Indications for Use
Indicated for patients requiring cardiovascular support due to refractory ventricular failure, cardiogenic shock, unstable refractory angina, impending infarction, mechanical complications of acute myocardial infarction (e.g., ventricular septal defect, mitral regurgitation, papillary muscle rupture), ischemia-related intractable ventricular arrhythmias, high-risk surgical/angiography/angioplasty procedures, septic shock, weaning from cardiopulmonary bypass, intraoperative pulsatile flow generation, or failed angioplasty/valvuloplasty.
Regulatory Classification
Identification
An intra-aortic balloon and control system is a prescription device that consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies, and a control system for regulating the inflation and deflation of the balloon. The control system, which monitors and is synchronized with the electrocardiogram, provides a means for setting the inflation and deflation of the balloon with the cardiac cycle.
Special Controls
*Classification.* (1) Class II (special controls) when the device is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure. The special controls for this device are:(i) Appropriate analysis and non-clinical testing must be conducted to validate electromagnetic compatibility and electrical safety of the device;
(ii) Software verification, validation, and hazard analysis must be performed;
(iii) The device must be demonstrated to be biocompatible;
(iv) Sterility and shelf-life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components;
(v) Non-clinical performance evaluation of the device must demonstrate mechanical integrity, durability, and reliability to support its intended purpose; and
(vi) Labeling must include a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(2) Class III (premarket approval) when the device is indicated for septic shock and pulsatile flow generation.
(c)
*Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required.* A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 31, 2014, for any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976, or that has, on or before March 31, 2014, been found to be substantially equivalent to any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976. Any other intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
Percor-STAT-DL 9.5 Fr. 25cc, 34cc and 40cc Intra-Aortic Balloon (IAB) Catheter with Alternate "B" Membrane for Optional Sheathless Insertion (K980780)
Submission Summary (Full Text)
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K994157
## MAR 1 3 2000 10(k) SUMMARY OF SAFETY AND EFFECTIVENESS
## FOR
# DATASCOPE 8Fr. Polyimide
# 25, 34 & 40cc Intra-Aortic Balloon Catheters
(Prepared in accordance with 21 CFR Part 807.92)
Pursuant to Section 513(I)(3)(A) of the Food, Drug, and Cosmetic act, Datascope Corp. is required to submit this Premarket Notification either an "…adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Datascope Corp. chooses to submit a summary of information respecting safety and effectiveness.
#### GENERAL INFORMATION A.
| Submitter: | Datascope Corp.<br>Cardiac Assist Division |
|-----------------|---------------------------------------------------------------------------|
| Address: | 15 Law Drive<br>Fairfield, NJ 07004 |
| Contact Person: | Whitney G. Törning<br>Director, Regulatory Affairs & Product Surveillance |
#### DEVICE INFORMATION B.
| Generic Name: | Intra-Aortic Balloon (IAB) |
|----------------------|----------------------------------------------------------------------|
| Trade Name: | Datascope 8Fr. Intra-Aortic Balloon (IAB) |
| Classification Name: | Intra-Aortic Balloons (IABs) are classified under<br>21 CFR 870.3535 |
Product Code: 74DSP
#### C. PREDICATE DEVICE INFORMATION
Datascope's Percor STAT-DL® Intra-Aortic Balloon is substantially equivalent to the following marketed devices:
- K980385 8Fr. Co-Lumen (CL) Intra-Aortic Balloon 34cc and 40cc (IAB) & Accessories
- K980780- Percor-STAT-DL 9.5 Fr. 25cc, 34cc and 40cc Intra-Aortic Balloon (IAB) Catheter with Alternate "B" Membrane for Optional Sheathless Insertion.
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#### DEVICE DESCRIPTION/INTENDED USE D.
The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations:
- · Refractory ventricular failure
- · Cardiogenic shock
- · Unstable refractory angina
- · Impending infarction
- Mechanical complications due to acute myocardial infarction .
- · Ischemic related intractable ventricular arrhythmias
- · Cardiac support for high risk surgical patients and coronary angiography or angioplasty patients
- · Septic shock
- · Weaning from cardiopulmonary bypass
- · Interoperative pulsatile flow generation
- · Support for failed angioplasty and valvuloplasty
#### TECHNOLOGICAL CHARACTERISTICS E.
Datascope's 8Fr. Polyimide 25, 34 & 40cc IAB is substantially equivalent to the predicate devices with regard to its indications for use. They differ technologically respecting material grade and chemical composition of the components. The difference in material grade and chemical composition has been demonstrated not to affect safety or efficacy of the device.
#### F. NON-CLINICAL TESTS
The results of in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed devices.
#### G. CLINICAL TESTS
There have been no clinical evaluations of the new device.
#### H. CONCLUSIONS
Based on the information presented in this 510(k) premarket notification, Datascope's 8Fr. Polyimide IAB is considered substantially equivalent to Datascope's currently marketed IABs.
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing left and appears to be in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 2000
Ms. Whitney Törning Datascope Corporation Cardiac Assist Division 15 Law Drive, CN 40011 Fairfield, NJ 07004
Re: K994157 Datascope's 8FR. Polymide 25 cc, 34 cc and 40 cc Intra-Aortic Balloon Catheters Requlatory Class: III (three) Product Code: 74DSP November 29, 1999 Dated: December 9, 1999 Received:
Dear Ms. Törning:
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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 through 542 of the Act
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### Page 2 - Ms. Whitney Törning
for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "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,
Sot. Bute R. Campirelle
Celia M. Witten, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# 510(k) Number (if known):_K994/57
Device Name: Datascope's 8Fr. Polyimide 25, 34 & 40cc Intra-Aortic Balloon Catheters
Indications for Use:
- 1. Refractory ventricular failure.
- Cardiogenic shock. 2.
- Unstable refractory angina. 3.
- Impending infarction. 4.
- Mechanical complications due to acute myocardial infarction, i.e., ventricular న. septal defect, mitral regurgitation or papillary muscle rupture.
- Ischemia related intractable ventricular arrhythmias. Q.
- Cardiac support for high risk general surgical patients and coronary 7. angiography/angioplasty patients.
- Septic shock. 8.
- Weaning from cardiopulmonary bypass. 9.
- Intraoperative pulsatile flow generation. 10.
- Support for failed angioplasty and valvuloplasty. 11.
This information can be found in Volume 1 (Section 3 - Attachment II) of our Premarket Notification under the section titled "II. Indications".
# (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 Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K 994157
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.
