The Blom-Singer Indwelling TEP Occluder is indicated for anterograde placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of the indwelling occluder is performed by a qualified, trained medical professional. This device is for use with healed, intact tracheoesophageal puncture fistulas only.
Device Story
Blom-Singer Indwelling TEP Occluder is a medical-grade silicone device designed for fistula maintenance and prevention of liquid leakage from the esophagus into the trachea following total laryngectomy. Unlike voice prostheses, this device does not support voicing. It is placed anterogradely by a clinician into a healed, intact tracheoesophageal puncture fistula using a gel cap insertion system. The indwelling nature eliminates the need for patient-performed routine removal and cleaning. The device is available in 16 and 20 French sizes, including a large esophageal flange version for patients with unique physiology to improve seal. By maintaining the fistula and preventing aspiration, the device supports patient comfort and safety post-laryngectomy.
Clinical Evidence
Bench testing only. Non-clinical tests performed included Pressure Decay, Flange Retention Force, and Gel cap Insertion method to demonstrate functional equivalency to predicate designs.
Technological Characteristics
Medical grade silicone; latex-free. Anterograde placement via gel cap insertion system. Available in 16 and 20 French sizes. Includes large esophageal flange variant. Non-voicing design. Mechanical device; no software or energy source.
Indications for Use
Indicated for patients post-total laryngectomy with healed, intact tracheoesophageal (TE) puncture fistulas requiring fistula maintenance and prevention of esophageal-to-tracheal liquid leakage. Placement/replacement must be performed by a qualified medical professional.
Regulatory Classification
Identification
A laryngeal prosthesis (Taub design) is a device intended to direct pulmonary air flow to the pharynx in the absence of the larynx, thereby permitting esophageal speech. The device is interposed between openings in the trachea and the esophagus and may be removed and replaced each day by the patient. During phonation, air from the lungs is directed to flow through the device and over the esophageal mucosa to provide a sound source that is articulated as speech.
Special Controls
*Classification.* Class II (special controls). The device, when it is a voice amplification device, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
Blom-Singer Dummy Voice Prosthesis with Retention Collar (K812982)
Submission Summary (Full Text)
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K093258
# Helix Medical, LLC 510(k) Summary Blom-Singer® Indwelling TEP Occluder
#### I NAME OF SUBMITTER
Helix Medical, LLC 1110 Mark Ave. Carpinteria, CA 93013 Contact Person: Cynthia Anderson Establishment Registration Number: 2025182
MAR - 3 2010
### DEVICE NAME AND CLASSIFICATION II
Proprietary Name: Blom-Singer® Indwelling TEP Occluder Common or Usual Name: TEP Occluder
Class II, 21 CFR 874.3730 The Blom-Singer Indwelling TEP Occluder is neither a life-supporting nor a lifesustaining device. It is not considered an implant.
III PREDICATE DEVICES
K932120, Blom-Singer Indwelling Low Pressure Voice Prosthesis, April 15, 1994
K812982, Blom-Singer Dummy Voice Prosthesis with Retention Collar, November 24, 1981
Related accessories being provided with product:
- inserter stick -
- flushing device -
- flange introducer -
- gel caps ー
- lubricant
#### IV DESCRIPTION
The Blom-Singer Indwelling TEP Occluder is designed to provide fistula maintenance while preventing leakage of liquids from the esophagus into the trachea after total laryngectomy. The Indwelling TEP Occluder has been modified from its predicate devices by the inclusion of the Indwelling Low Pressure Voice Prosthesis design, and is now available in 16 and 20 fr. Sizes. In addition, this device will be offered in a large esophageal flange version.
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This version will be identical except for an esophageal flange which is greater in diameter to deter leakage around the device in individuals with unique physiology. These devices are manufactured from medical grade silicone and are latex-free.
#### V INTENDED USE
The Blom-Singer Indwelling TEP Occluder is indicated for anterograde placement in and maintenance of the TE puncture following total laryngectomy when placement, on. replacement, of an indwelling occluder is performed by a qualified, trained medical professional. This device is for use with healed, intact tracheoesophageal puncture fistulas only.
## VI TECHNOLOGICAL REQUIREMENTS
The Blom-Singer® Indwelling TEP Occluder is designed to provide fistula maintenance while preventing leakage of liquids from the esophagus into the trachea after total laryngectomy. Voicing is not possible with this device. This device is for use with healed, intact tracheoesophageal puncture fistulas only and is placed by the clinician using an anterograde method. A gel cap insertion system facilitates placement. The use of an indwelling device means that routine removal and cleaning by the patient is not necessary.
There are two predicate devices to which equivalence of this device is claimed, both are manufactured from medical grade silicone and are latex-free. The first, Blom-Singer Indwelling Low Pressure Voice Prosthesis, provides fistula maintenance while preventing leakage of liquids from the esophagus into the trachea after total laryngectomy. This device is intended for voicing. Anterograde placement is performed by a clinician in a surgically-created fistula between the trachea and esophagus.
The Blom-Singer Dummy Duckbill with Retention Collar (now known as Blom-Singer TEP Occluder) is designed to provide fistula maintenance and prevent leakage of liquids from the esophagus into the trachea after total laryngectomy. It is not intended for voicing and does not require placement by a clinician.
Functional equivalency tests have been performed on the Blom-Singer devices which demonstrate the equivalency of device performance with the three designs. Non-clinical tests referenced for a determination of substantial equivalence are Pressure Decay. Flange Retention Force, and Gel cap Insertion method. The conclusions drawn from the nonclinical tests demonstrate that the device is safe, as effective, and performs as well or better than the predicate devices.
Accessory Devices:
- flange introducer -
- gel caps
- inserter sticks -
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the caduceus symbol.
MAR 3 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Helix Medical, LLC c/o Ms. Cynthia Anderson Regulatory Affairs 1110 Mark Ave. Carpinteria, CA 93013
Re: K093258
Trade/Device Name: Blom-Singer Indwelling TEP Occluder Regulation Number: 21 CFR 874.3730 Regulation Name: Laryngeal prosthesis (Taub design) Regulatory Class: Class II Product Code: EWL Dated: January 28, 2010 Received: January 29, 2010
Dear Ms. Anderson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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Page 2 - Ms. Cynthia Anderson
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1.1.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Ruh. Jurner f
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use Statement
510(k) Number: K093258/S002
Device Name: Blom-Singer Indwelling TEP Occluder
Indications for Use:
The Blom-Singer Indwelling TEP Occluder is indicated for anterograde placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of the indwelling occluder is performed by a qualified, trained medical professional. This device is for use with healed, intact tracheoesophageal puncture fistulas only.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE, IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 DFR 801.109)
OR
Over-The-Counter Use
K093258
Daniel C. Clapper
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K093258
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.
