(19 days)
No
The summary describes a mechanical inflation device with a manometer and does not mention any AI/ML terms or functionalities.
Yes
The device is used for "therapeutic procedures" as stated in the "Intended Use / Indications for Use" section.
Yes
The "Intended Use / Indications for Use" states that the device is used for "diagnostic and therapeutic procedures."
No
The device description explicitly states it is a "disposable inflation device with a manometer," indicating it is a physical hardware device, not software only.
Based on the provided information, the Relieva Sinus Balloon Inflation Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Relieva Sinus Balloon Inflation Device is used in vivo (within the living body) to inflate and deflate a balloon during a surgical procedure (balloon dilation of sinus ostia). It directly interacts with the patient's anatomy.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing performed on samples outside the body.
Therefore, the device is a surgical tool used for a therapeutic and potentially diagnostic procedure performed directly on the patient, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Relieva Sinus Balloon Inflation Device is recommended for use to inflate the balloon, monitor the pressure within the balloon and deflate the balloon while performing balloon dilation procedures of the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.
Product codes
LRC
Device Description
The Relieva Sinus Balloon Inflation Device is a disposable inflation device with a manometer that measures pressures ranging from vacuum to gauge capacity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sinus ostia and spaces within the paranasal sinus cavities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Products were tested to ensure conformance to product specification. Testing included:
- Pressure Accuracy .
- Pressure Decay .
- Predicate Comparison .
- Pressure Integrity .
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4420 Ear, nose, and throat manual surgical instrument.
(a)
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.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.
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AUG 3 1 2005
510(k) Summary
| General Information | |
|---|---|
| Classification: | Class I |
| Classification Name: | Ear, Nose & Throat Manual Surgical Instrument |
| Regulation Code: | 21 CFR 874.4420 |
| Product Code: | LRC |
| Trade Name: | Relieva Sinus Balloon Inflation Device |
| Submitter: | Acclarent, Inc. |
| 1525-B O'Brien Drive | |
| Menlo Park, CA 94025 | |
| Contact: | Su-Mien Chong |
| VP, Clinical, Regulatory and Quality | |
| Date Revised: | 25 August 2005 |
Intended Use
The Relieva Sinus Balloon Inflation Device is recommended for use to inflate the balloon, monitor the pressure within the balloon and deflate the balloon while performing balloon dilation procedures of the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.
Device Description
The Relieva Sinus Balloon Inflation Device is a disposable inflation device with a manometer that measures pressures ranging from vacuum to gauge capacity.
Materials
All materials used in the manufacture of the Relieva Sinus Balloon Inflation Device are suitable for their intended use and have been used in numerous previously cleared products.
1
Testing
Products were tested to ensure conformance to product specification. Testing included:
- Pressure Accuracy .
- Pressure Decay .
- Predicate Comparison .
- Pressure Integrity .
Summary of Substantial Equivalence
The Relieva Sinus Balloon Inflation Device is substantially equivalent to marketed predicate devices with respect to intended use and technological characteristics.
Comparison Chart of Relieva Sinus Balloon Inflation Device and Predicate Devices
| | Relieva Sinus
Inflation
Device | Relieva Sinus
Balloon
Catheter | Circular Cutting
Punch | Antrum Curette |
|--------------------------|-------------------------------------------------|--------------------------------------|------------------------------------|------------------------------------|
| Manufacturer | Acclarent | ExploraMed NC1 | Karl Storz
Endoscopy
America | Karl Storz
Endoscopy
America |
| 510(k) Number | K052198 | K043527 | Pre-Amendments | Pre-Amendments |
| CFR Section | 874.4420 | 874.4420 | 874.4420 | 874.4420 |
| Device
Classification | I | I | I | I |
| Product Code | LRC | LRC | LRC | LRC |
| Intended Use | Inflation &
deflation of
dilation balloon | Dilation of tissue | Dilation of tissue | Dilation of tissue |
| Working
Diameter | 8mm | 3mm, 5mm,
7mm | 4.5mm | 5mm |
| Working
Length | 20 cm | 30cm | 18cm | 19cm |
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing its wings. The eagle is facing to the right.
Public Health Service
AUG 3 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Acclarent, Inc. c/o Su-Mien Chong VP Cinical, Regulatory and Quality 1525-B O'Brien Drive Menlo Park, CA 94025
Re: K052198
Trade/Device Name: Relieva Sinus Balloon Inflation Device Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, nose, and throat manual surgical instrument Regulatory Class: Class I Product Code: LRC Dated: August 11, 2005 Received: August 12, 2005
Dear Ms. Chong
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications felerenced above and nave determined in the are and and the summer of the marketed in interstate for use stated in the enclosure) to regard mannent date of the Medical Device Amendments, or to comments to May 20, 1978, the exactions with the provisions of the Federal Food. Drug, devices that have been recalismed in abece approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval app and Cosment Act (Act) market the device, subject to the general controls provisions of the Act. The 1 ou may, merciore, market the act include requirements for annual registration, listing of general controls provisions of the sice, 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 If your device is classified (see aborto) into Existing major regulations affecting your device can may be subject to suen additional connections, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous neements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 1 Dri 3 issuated or a basevice complies with other requirements of the Act that TDA has made a determination an administered by other Federal agencies. You must of any Federal statutes and regulations and admited to: registration and listing (21 Comply with an the Her s requirements, and manufacturing practice requirements as set CFK Fart 807), adoling (21 CFR Part 820), good if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Su-Mien Chong
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maneting your antial equivalence of your device to a legally premitsel notification. The PDA miding of baction 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), please If you desire specific advice for your ac 101 x 27-8910. Also, please note the regulation entitled, Colliact the Office of Complanoo at (301) SET 971 SET Part 807.97). You may obtain Misorananing by Telefone to premail.com in the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or Mandracturers, International and Ocusal http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
David M. Whipple
David M. Whipple Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
Relieva Sinus Balloon Inflation Device
The Relieva Sinus Balloon Inflation Device is recommended for use to inflate the balloon, monitor the pressure within the balloon and deflate the balloon while performing balloon dilation procedures of the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.
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 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K052498
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