K021557 · Cook, Inc. · FOZ · May 30, 2003 · General Hospital
Device Facts
Record ID
K021557
Device Name
SPECTRUM SILICONE CATHETER
Applicant
Cook, Inc.
Product Code
FOZ · General Hospital
Decision Date
May 30, 2003
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.5200
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The COOK Spectrum® Silicone Catheter is used for the intravenous administration of nutrient fluids, chemotherapeutic agents and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring. The catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (CRBSI). It is not intended to be used as a treatment for existing infections. Catheters are available in single and double lumen PICC, and single, double and triple lumen CVC. The device is supplied sterile and intended for one-time use.
Device Story
COOK Spectrum® Silicone Catheter; single, double, or triple lumen central venous catheter (CVC) or peripherally inserted central catheter (PICC). Impregnated with minocycline and rifampin to reduce risk of catheter-related bloodstream infections (CRBSI). Used for intravenous fluid/drug administration, blood sampling, and venous pressure monitoring. Sterile, single-use device. Clinical benefit: reduction in CRBSI incidence. Evaluated via prospective, randomized clinical trial comparing treatment (antimicrobial) vs. control cohorts; primary outcome definite CRBSI; secondary safety metrics included catheter-related complications (leak, bleeding, thrombosis).
Clinical Evidence
Prospective, randomized clinical trial comparing antimicrobial-impregnated catheter to control. Primary endpoint: definite CRBSI occurrence. Results demonstrated significant reduction in CRBSI rate for treatment cohort. Safety evaluated by comparing complication rates (leak, bleeding, thrombosis) and repositioning incidence. Post-removal evaluation included zone of inhibition testing against MRSA and culture techniques (roll plate/sonication) for colonization.
Technological Characteristics
Silicone intravascular catheter; single, double, or triple lumen configurations; 4Fr to 12Fr sizes; 8-60 cm lengths. Impregnated with minocycline and rifampin. Sterile, single-use. Biocompatibility, tensile, vacuum/pressure, flow, and shelf-life testing performed. HPLC and zone of inhibition testing used for antimicrobial verification.
Indications for Use
Indicated for patients requiring intravenous therapy, including nutrient fluid administration, chemotherapy, drug delivery, blood sampling, and venous pressure monitoring via central venous or peripherally inserted central catheters. Not indicated for treatment of existing infections.
Regulatory Classification
Identification
An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.
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K021557
Cook Incorporated P.O. Box 489 Bloomington, IN 47402-0489 Phone: 800 468-1379 www.cookgroup.com
# MAY 3 0 2003
# 510(k) Summary
Page 1 of 2
| Submitted by: | Cook Incorporated |
|--------------------------|------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Bosley, MBA<br>Ph: (812) 339-2235 x2093<br>Fax: (812) 332-0281 |
| Date Prepared: | March 26, 2003 |
| 510(k) #: | K021557 |
| Device: | COOK Spectrum® Silicone Catheter |
| Trade Name: | Intravascular Catheter, Central Venous Catheter |
| Common/Usual Name: | Intravascular Catheter, Therapeutic, Long-term and Short-term |
| Proposed Classification: | 21 CFR Part 880.5970 (80 LJS), Class II<br>21 CFR Part 880.5200 (80 FOZ), Class II |
### Device Description:
The COOK Spectrum® Silicone Catheters are single, double or triple lumen central venous catheters; and single and double lumen peripherally inserted central catheters available in sizes ranging from 4Fr single lumen to 12Fr double lumen. including an 8Fr triple lumen device. Catheter lengths range from 8 to 60 cm. The catheter is impregnated with an antimicrobial combination of minocycline and rifampin. The device is supplied sterile and intended for one-time use.
# Intended Use:
The COOK Spectrum® Silicone Catheter is used for the intravenous administration of nutrient fluids, chemotherapeutic agents and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring. The catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (CRBSI). It is not intended to be used as a treatment for existing infections. Catheters are available in single and double lumen PICC, and single, double and triple lumen CVC.
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# Predicate Devices:
The COOK Spectrum® Silicone Catheter is comparable in terms of intended use and technological characteristics to predicate intravascular catheters used to sample blood, administer fluids intravenously, and to monitor venous pressure.
| Manufacturer | Device | 510(k) Number |
|---------------------------|---------------------------------------|---------------|
| COOK Incorporated | Silicone Catheter | A137605 |
| COOK Incorporated | Single Lumen Urethane PICC | K992198 |
| COOK Incorporated | Double Lumen Urethane PICC | K010034 |
| COOK Incorporated | Spectrum® Catheter | K950118 |
| COOK Incorporated | Spectrum® Ventricular Catheter | K011812 |
| COOK Urological/OB/GYN | Spectrum® Silicone Foley Catheter | K000251 |
| Arrow International, Inc. | ARROWgard Blue PlusTM Multi-Lumen CVC | K993691 |
### Substantial Equivalence:
The device will be manufactured according to specified process controls, adhering to Good Manufacturing Practices and Quality System Regulations, undergoing processing, sterilization and packaging procedures similar to devices currently manufactured and marketed by Cook Incorporated. This device is similar with respect to indications for use and design to predicate devices in terms of section 510(k) substantial equivalence.
### Test Data:
The COOK Spectrum® Silicone Catheter has undergone biocompatibility, performance, and clinical testing which provide reasonable assurance of safety and effectiveness for its intended use. Testing includes:
- Biocompatibility
- . Tensile Testing
- Vacuum and Pressure Testing
- HPLC and Zone of Inhibition Testing ●
- Flow Testing .
- Shelf-Life Testing .
# Clinical Evaluation:
In this prospective, randomized clinical trial with well matched treatment and control cohorts, results indicate that the COOK Spectrum® Silicone Catheter can significantly reduce the rate of catheter-related bloodstream infection (CRBSI). Clinical safety was evaluated by comparing rates of each complication (other than CRBSI) for the treatment cohort versus the control cohort. To determine effectiveness, the occurrence of definite CRBSI was evaluated as the primary outcome measure. When available, catheters were evaluated after removal from patients by zone of inhibition testing against MRSA (CI4371). Determination of catheter colonization was based on results of any culture from the subcutaneous and tip segment of the catheter using roll plate and sonication culture techniques. Performance was evaluated by comparing the incidence of catheter removal due to catheter leak, bleeding around the catheter thrombosis between the two study groups and by comparing the incidence of catheter repositioning.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three wing-like shapes, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the perimeter of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 0 2003
Ms. Jennifer Bosley, MBA Regulatory Affairs Coordinator Cook. Incorporated 925 South Curry Pike P.O. Box 489 Bloomington, Indiana 47402-0489
Re: K021557
Trade/Device Name: COOK Spectrum® Silicone Catheter Regulation Number: 880.5200, 880.5970 Regulation Name: Intravascular Catheter, Percutaneous, Implanted, Long-term Intravascular Catheter Regulatory Class: II Product Code: FOZ, LJS Dated: March 26, 2003 Received: March 27, 2003
Dear Ms. Bosley:
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 (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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.
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Page 2 - Ms. Bosley
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.
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 vour 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 (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 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/dsma/dsmamain.html
Sincerely yours
Susan Runse
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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#### Indications for Use Statement
510(k) Number (if known):
K021557
Device Name:
COOK Spectrum® Silicone Catheter
#### Indications for Use:
The COOK Spectrum® Silicone Catheter is used for the intravenous administration of nutrient fluids, chemotherapeutic agents and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring. The catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheterrelated bloodstream infections (CRBSI). It is not intended to be used as a treatment for existing infections. Catheters are available in single and double lumen PICC: and single, double and triple lumen CVC. The device is supplied sterile and intended for one-time use.
# PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Salvatore Cucenti
Division Sian-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices
510(k) Number: K021557
V Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
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.
