K993199 · Ferraris Medical, Inc. · CAF · Mar 28, 2000 · Anesthesiology
Device Facts
Record ID
K993199
Device Name
POCKET CHAMBER VALVED AEROSOL HOLDING CHAMBER
Applicant
Ferraris Medical, Inc.
Product Code
CAF · Anesthesiology
Decision Date
Mar 28, 2000
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 868.5630
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Pocket Chamber Valved Aerosol Holding Chamber is intended to assist with the delivery of aerosolized medications when used in conjunction with commercialized MDI canisters with the associated activator elbow. The spacer device is indicated to assist in the treatment of patients with lung disease such as, but not limited to, asthma, emphysema, chronic bronchitis, and cystic fibrosis.
Device Story
The Pocket Chamber is a cylindrical valved aerosol holding chamber (spacer) used to facilitate medication delivery from metered-dose inhaler (MDI) canisters. The device features a cylindrical tube (approx. 3.1 inches long by 4.5 cm wide) with an MDI receptacle designed to prevent off-center actuations and a one-way valve located between the mouthpiece and the body. It is used by patients to improve the efficiency of aerosolized drug delivery. The device acts as an interface between the MDI and the patient's airway, ensuring consistent medication delivery. It is a non-powered, mechanical accessory.
Clinical Evidence
Bench testing only. Performance was evaluated using a Cascade Impactor Test comparing the subject device to the predicate AeroChamber and an MDI actuator without a spacer. Metrics included total dose, respirable dose, mass median aerodynamic diameter, and geometric standard deviation. Results showed comparable performance. Resistance to flow testing on the one-way valve and validation of cleaning instructions were also performed.
Technological Characteristics
Cylindrical tube, 3.1 inches long by 4.5 cm wide. Features a one-way valve at the mouthpiece-body junction and an MDI receptacle. Non-powered, mechanical device. No software or electronic components.
Indications for Use
Indicated for patients with lung disease, including asthma, emphysema, chronic bronchitis, and cystic fibrosis, requiring assistance with aerosolized medication delivery via MDI canisters.
Regulatory Classification
Identification
A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.
Predicate Devices
AeroChamber Aerosol Holding Chamber (Monaghan Medical Corporation)
Submission Summary (Full Text)
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MAR 2 8 2000
K993199
## 510(k) SUMMARY
## Ferraris Medical. Inc. Pocket Chamber Valved Aerosol Holding Chamber
# Submitter's Name. Address. Telephone Number. Contact Person and Date Prepared
| Mr. David R. Malys | Jonathan S. Kahan, Esq. |
|-------------------------|-----------------------------|
| President | Hogan & Hartson L.L.P. |
| Ferraris Medical, Inc. | 555 Thirteenth Street, N.W. |
| 9681 Wagner Road | Washington, DC 20004-1109 |
| Post Office Box 344 | Telephone: (202) 637-5794 |
| Holland, New York 14080 | Facsimile: (202) 637-5910 |
## Date Prepared:
September 23, 1999
#### Name of Device and Name/Address of Sponsor
Ferraris Medical, Inc. Pocket Chamber Valved Aerosol Holding Chamber
Mr. David R. Malys President Ferraris Medical, Inc. 9681 Wagner Road Post Office Box 344 Holland, New York 14080
## Common or Usual Name
Spacer; Aerosol Holding Chamber
### Classification Name
Accessory to a nebulizer
#### Predicate Devices
Monaghan Medical Corporation's AeroChamber Aerosol Holding Chamber
### Intended Use
The Pocket Chamber Valved Aerosol Holding Chamber is intended to assist with the delivery of aerosolized medications when used in conjunction with commercialized MDI canisters with the associated activator elbow. The spacer device is indicated to assist in the treatment of patients with lung disease such as, but not limited to, asthma, emphysema, chronic bronchitis, and cystic fibrosis.
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## Technological Characteristics and Substantial Equivalence
The Pocket Chamber Valved Aerosol Holding Chamber is a cvlindrical tube. approximately 3.1 inches long by 4.5 cm wide, and accepts the MDI manufacturer's mouthpiece. The MDI receptacle has an orifice of size and shape similar to the MDI mouthpiece. The device is designed to prevent offcenter actuations. A one-way valve is located at the juncture between the mouthpiece and the body. The Pocket Chamber Valved Aerosol Holding Chamber is substantially equivalent to the AeroChamber.
#### Performance Data
Ferraris performed the Cascade Impactor Test comparing the Pocket Chamber Valved Aerosol Holding Chamber with the AeroChamber and an MDI actuator without a spacer device for four categories of drugs. The Pocket Chamber Valved Aerosol Holding Chamber performed comparably in terms of total dose, respirable dose, mass median aerodynamic diameter; and geometric standard deviation. In addition, resistance to flow testing on the one-way valve, and validation of the cleaning instructions demonstrate that the Pocket Chamber performs in accordance with the device's specifications.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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# MAR 2 8 2000
Mr. Jonathan S. Kahan Ferraris Medical, Inc. c/o Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004-1109
Re : K993199 Pocket Chamber Valved Aerosol Holding Chamber Regulatory Class: II (two) 73 CAF Product Code: Dated: December 30, 1999 Received: December 30, 1999
Dear Mr. Kahan:
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 reqistration, 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 requlation 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Jonathan S. Kahan
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) 594-4648. 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" (21 CFR 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,
Jean-Nicholas fer,
James E. Dillard III Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
#### Ferraris Medical, Inc.'s Pocket Chamber Valved Aerosol Device Name: Holding Chamber
Indications for Use:
The Pocket Chamber Valved Aerosol Holding Chamber is intended to assist with the delivery of aerosolized medications when used in conjunction with commercialized MDI canisters with the associated activator elbow. The spacer device is indicated to assist in the treatment of patients with lung disease such as, but not limited to, asthma, emphysema, chronic bronchitis, and cystic fibrosis.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. A. Whitten
Prescription Use (Per 21 C.F.R. 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.
