K120280 · Acclarent, Inc. · LRC · Nov 5, 2012 · Ear, Nose, Throat
Device Facts
Record ID
K120280
Device Name
RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM
Applicant
Acclarent, Inc.
Product Code
LRC · Ear, Nose, Throat
Decision Date
Nov 5, 2012
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 874.4420
Device Class
Class 1
Attributes
Therapeutic
Indications for Use
For patients aged 18 and older, the Relieva Seeker Balloon Sinuplasty System is intended to provide a means to access the frontal sinus space and to dilate the frontal recess, frontal sinus ostia and spaces within the frontal sinus cavity for diagnostic and therapeutic procedures. In addition, the device is intended to illuminate within and transilluminate across nasal and sinus structures.
Device Story
Integrated sinus dilation system comprising low-profile rail, balloon catheter, handle, and integrated illumination system with illuminated ball tip. Distal end permanently curved for frontal ostium access. Used by physicians in clinical settings to access and dilate frontal sinus spaces. Illumination system provides light for transillumination of nasal/sinus structures to assist navigation. Balloon inflation provides tissue expansion. Output is physical dilation of sinus ostia and visual guidance via transillumination. Benefits include minimally invasive access and dilation of frontal sinus anatomy.
Clinical Evidence
No clinical data. Bench testing only. Testing included dimensional attributes, cycle fatigue, balloon burst, bond separation, and biocompatibility. Sterilization validated per AAMI/ANSI/ISO 11135-1:2007; packaging shelf life validated per ASTM F1980-07, ISTA 2A:2011, ASTM F88-09, ASTM F2096-11, F1886, and F1929-98.
Technological Characteristics
Integrated balloon catheter and illumination system. Distal end permanently curved. Sterilization: Ethylene oxide (AAMI/ANSI/ISO 11135-1:2007). Biocompatibility per ISO 10993-7:2008. Packaging standards: ASTM F1980-07, ISTA 2A:2011, ASTM F88-09, ASTM F2096-11, F1886, F1929-98.
Indications for Use
Indicated for patients aged 18 and older requiring access to the frontal sinus space and dilation of the frontal recess, frontal sinus ostia, and frontal sinus cavity spaces for diagnostic and therapeutic procedures; also indicated for illumination and transillumination of nasal and sinus structures.
Regulatory Classification
Identification
An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.
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120080
NOV 5 2012
## 510(k) SUMMARY
Sponsor/Submitter: Acclarent, Inc. 1525-B O'Brien Drive Menlo Park, California 94025 Contact Person: Daniel Harfe Director, Clinical and Regulatory Affairs Phone: (650) 687-6056 Fax: (650) 687-4847 January 27, 2012 Date of Submission: Device Trade Name: Relieva Seeker Balloon Sinuplasty System Common Name: Sinus Dilation System Device Classification: Class I 21 CFR 874.4420 Regulation Number: Ear, Nose, and Throat Manual Surgical Instrument Classification Name: LRC Product Code: Predicate Devices: Relieva Spin Sinus Dilation System (K111875) Entellus Medical XprESS Multi-Sinus Dilation Tool (K102003) Relieva Luma Sinus Illumination System (K071845) The Relieva Seeker Balloon Sinuplasty System (Seeker) is an integrated Device Description: device with a low-profile rail, balloon catheter, sinus illumination system with an illuminated ball tip, and a handle. The sinus balloon may be inflated to dilate the frontal recess, frontal sinus ostia, and
spaces within the frontal sinus cavity.
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Indications for Use:
For patients aged 18 and older, the Relieva Seeker Balloon Sinuplasty System is intended to provide a means to access the frontal sinus space and to dilate the frontal recess, frontal sinus ostia and spaces within the frontal sinus cavity for diagnostic and therapeutic procedures. In addition, the device is intended to illuminate within and transilluminate across nasal and sinus structures.
Technological Characteristics: The Seeker Balloon Sinuplasty System combines features of a frontal ostium seeker with the tissue expansion effect of balloon dilation. The distal end of the device is permanently curved to optimize frontal ostium access. Light from an extendable integrated illumination system can be seen via transillumination.
Performance Data:
Bench testing met all acceptance criteria for attributes such as dimensional attributes, cycle fatigue, balloon burst, and bond separation. Testing also showed that the Seeker Balloon Sinuplasty System is biocompatible.
Sterilization of the subject device is achieved by ethylene oxide, which was validated according to AAMI/ANSI/ISO 11135-1: 2007 and demonstrated a sterility assurance level of 10 °. The method used for sterilization validation was the overkill (half-cycle approach) in a fixed chamber. Ethylene oxide residuals were tested and met ISO 10993-7:2008 requirements. The subject device is not tested nor labeled as "non-pyrogenic".
Packaging shelf life was established per ASTM F1980-07, ISTA 2A:2011, ASTM F88-09, ASTM F2096-11, F1886, and F1929-98 requirements.
Clinical data were not necessary for the Seeker Balloon Sinuplasty System. The performance data demonstrate that the device performs as intended.
The Relieva Seeker Sinus Dilation System is substantially equivalent to the predicate devices
Summary of Substantial Equivalence:
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NOV
5 200
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Acclarent, Inc. % Mr. Daniel Harfe Director, Regulatory & Clinical, Rhinology 1525-B O'Brien Drive Menlo Park, CA 94025
Re: K120280
Trade/Device Name: Relieva Seeker Balloon Sinuplasty System Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, nose, and throat manual surgical instrument Regulatory Class: Class I Product Code: LRC Dated: October 19, 2012 Received: October 22, 2012
Dear Mr. Harfe:
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.
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
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Page 2 - Mr. Daniel Harfe
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/ucm115809.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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Malvina B. Eydelman. M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## APPENDIX B: INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K120280 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Relieva Seeker Balloon Sinuplasty™ System |
| Common Name: | Sinus Dilation System |
| Indications For Use: | For patients aged 18 and older, the Relieva Seeker Balloon Sinuplasty System is intended to provide a means to access the frontal sinus space and to dilate the frontal recess, frontal sinus ostia and spaces within the frontal sinus cavity for diagnostic and therapeutic procedures. In addition, the device is intended to illuminate within and transilluminate across nasal and sinus structures. |
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
AND/OR
| Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---------------------------------------------|--|
|---------------------------------------------|--|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF. NEEDED)Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)
Daniel C. Clapp
Page / of
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
K120280 510(k) Number_
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.
