K022398 · Ballard Medical Products · BWH · Oct 11, 2002 · Ear, Nose, Throat
Device Facts
Record ID
K022398
Device Name
REUSABLE BRONCHIAL BIOPSY FORCEPS
Applicant
Ballard Medical Products
Product Code
BWH · Ear, Nose, Throat
Decision Date
Oct 11, 2002
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 874.4680
Device Class
Class 2
Indications for Use
Intended to remove, by cutting, a specimen of tissue for microscopic examination from the lungs or bronchial passageways. Patient population; Any patient demonstrating an abnormality or condition indicative of malignancy or benign obstruction as noted through bronchoscopy, x-ray, MRI, etc.
Device Story
Reusable bronchial biopsy forceps; manual instrument for tissue specimen collection. Operates via 4-bar linkage mechanism; transverse motion of handle finger spool/ring translates through control cable to actuate distal jaws. Used in clinical settings during bronchoscopy procedures; operated by physicians. Device enables tissue sampling for microscopic examination to assist in diagnosing lung/bronchial abnormalities or malignancies. Components fabricated from ASTM 302, 303, or 304 stainless steel; handle materials withstand multiple reprocessing cycles. Device provides mechanical cutting action to retrieve tissue samples.
Clinical Evidence
Bench testing only. Testing included functional, sterilization, reprocessing, and tensile strength evaluations to demonstrate performance equivalence to the predicate device.
Indicated for patients demonstrating abnormalities or conditions indicative of malignancy or benign obstruction in the lungs or bronchial passageways, as identified via bronchoscopy, x-ray, or MRI, requiring tissue specimen removal for microscopic examination.
Regulatory Classification
Identification
A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.
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022398
Image /page/0/Picture/1 description: The image shows the logo for Ballard Medical Products. The word "BALLARD" is written in large, bold, black letters. A thick black line is drawn underneath the word. Below the line, the words "MEDICAL PRODUCTS" are written in smaller, black letters.
Appendix F Attachment 3.0
OCT 11 2002
July 19, 2002
### 510(k) Premarket Notification Summary per 807.92(a)
| Submitter Information: | Cindy Ellis<br>Ballard Medical Products<br>12050 Lone Peak Parkway<br>Draper, UT 84020<br>Tel. 801-572-6800<br>Fax 801-572-6869 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Biopsy Forceps, Non-Electric, Reusable,<br>Non-Ridged for use with bronchoscopes |
| Trade Name: | NA |
| Classification Name: | Forceps, Biopsy, Bronchoscope (Non-Rigid)<br>Ear Nose and Throat<br>21 CFR 874.4680<br>77BWH |
| Predicate Device: | Olympus FB Series Biopsy Forcep<br>510(k) K962555 |
Device Description:
Image /page/0/Figure/8 description: This image shows a diagram of a medical instrument. The diagram labels the different parts of the instrument, including the jaws, sheath length, control cable, and distal sheath diameter. The jaws are shown open, and the diameter is measured in the closed position. The diagram also shows the length of the sheath and the location of the control cable.
Figure A-1: Bronchial Forceps w/ exploded, breakaway detail of distal end
Figure A-1 depicts all but a few reusable biopsy forceps designs. All operate on a 4-bar linkage arrangement as shown. Transverse motion of the control cable results in the pendulum motion of the handle consists of a slide, finger spool or finger ring arrangement and a thumb ring. The jaws are actuated by transverse motion of the finger spool that connects to the control cable is connected to the clevis. The
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linkages are hinged on small pins, the jaws rotate about an axle pin that is supported by the fork. With the exception of the handle, all the components are fabricated from ASTM 302, 303 or 304 stainless steel. The handle components are fabricated from a suitable material able to withstand several reprocessing cycles. The physical characteristics of this device as well as 510(k) predicate devices are described below.
Intended to remove, by cutting, a specimen of tissue for microscopic Intended Use: examination from the lungs or bronchial passageways. Patient population; Any patient demonstrating an abnormality or condition indicative of malignancy or benign obstruction as noted through bronchoscopy, x-ray, MRI, etc.
#### Technological Characteristics (equivalence to predicate device) per 807.92(a)(6): The general design characteristics and function of the Ballard device is similar to the Olympus device.
| Characteristic | Subject Device<br>This submission | Predicate Device<br>(Olympus) |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Typical label/advertising descriptors | | |
| Sheath length | 120cm | 105cm |
| Sheath diameter | 1.6mm | 1.6mm |
| Jaw diameter | 1.8mm | 1.8mm |
| Jaw geometry | Ellipsoid, fenestrated, no spike | Ellipsoid, fenestrated, no<br>spike plus various others |
| Recommended Reprocessing | | |
| Soak | Immediately after use | Immediately after use<br>5min to 3 hrs. |
| Enzymatic wash | Thoroughly clean with soft<br>brush to remove particulate.<br>Dry with sponge or gauze | N/A |
| Ultrasonic cleaning | 40KHz, 10 minutes | 30 minutes |
| Rinse | Clean running tap water | Clean running tap water |
| Autoclave | Pre-vacuum cycle<br>134°C<br>4min. exposure time<br>.2Mpa pressure<br>Gravity cycle<br>134°C<br>15 minute exposure time<br>.310Mpa pressure | Pre-vacuum<br>132°C-134°C<br>5min. exposure time |
#### Determination of Substantial Equivalence (non-clinical data) per 807.92(b)(1):
The following tests were performed on the Ballard Reusable Bronchial Biopsy Forceps.
- 1. Functional
- 2. Sterilization
- 3. Reprocessing
- 4. Tensile
#### Conclusions from non-clinical data per 807.92(b)(3):
Based on the indications for use, technological characteristics, and performance testing, the Ballard Reusable Bronchial Biopsy Forceps is safe and effective for its intended use.
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ballard Medical Products c/o Cindy Ellis Regulatory Affairs Specialist 12050 Lone Peak Parkway Draper, UT 84020
Re: K022398
Trade/Device Name: Reusable Bronchial Biopsy Forceps Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories. Regulatory Class: Class II Product Code: BWH Dated: July 19, 2002 Received: July 23, 2002
Dear Ms. Ellis:
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 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 (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.
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#### Page 2 - Cindy Ellis
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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## APPENDIX A ATTACHMENT 2.0
. . . .
1. 1. 1. 1.
Reusable Bronchial Biopsy Forceps
#
# INTENDED USE STATEMENT
Intended to remove, by cutting, a specimen of tissue for microscopic examination from the lungs.
# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PRESCRIPTION USE ***_*** OR OVER-THE-COUNTER USE **_**
BALLARD
1EDICAL PRODUCTS
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.
