(105 days)
The Relieva Sinus Balloon Dilation Catheter is intended to provide a means to dilate ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.
The Relieva Sinus Balloon Dilation Catheter will be provided in the following balloon sizes:
- 3 mm Sinus Balloon Catheter .
- 5 mm Sinus Balloon Catheter .
- 7 mm Sinus Balloon Catheter .
The family of Relieva Sinus Balloon Dilation Catheters allows for the enlargement of sinus ostia and paranasal spaces with a minimally invasive method. The Relieva Sinus Balloon Dilation Catheters are placed in the narrow opening over a guidewire. Once positioned the balloons are inflated with a high pressure inflation device that provides feedback as to the internal pressure of the balloon. After a few seconds at the desired balloon inflation pressure, the balloon can be deflated and removed or repositioned.
The provided text describes a medical device, the Relieva Sinus Balloon Dilation Catheter, and its substantial equivalence to predicate devices, but does not contain information regarding traditional acceptance criteria or a study proving the device meets those criteria, as one would expect for an AI-based device. Instead, it focuses on demonstrating conformance to product specifications and comparing it to existing, cleared devices.
This is a Class I medical device, which typically has lower regulatory hurdles compared to Class II or Class III devices, especially if it's considered substantially equivalent to pre-amendment devices or existing predicate devices. The validation relies on demonstrating that the device is safe and effective for its intended use through comparison and product testing, rather than a clinical study with acceptance criteria often seen for novel AI systems.
Here's an analysis based on the provided text, highlighting the absence of the requested information for an AI-based device:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Visual Inspection | Conforms to product specification |
| Dimensional Analysis | Conforms to product specification |
| Surface Finish | Conforms to product specification |
| Catheter Hub Leak | Conforms to product specification |
| Shaft to Hub Separation | Conforms to product specification |
| Balloon Inflation Cycle Fatigue | Conforms to product specification |
| Balloon Burst Pressure | Conforms to product specification |
Explanation: The document lists various tests performed ("Testing included: Visual Inspection, Dimensional Analysis, Surface Finish, Catheter Hub Leak, Shaft to Hub Separation, Balloon Inflation Cycle Fatigue, Balloon Burst Pressure") and states that "Products were tested to ensure conformance to product specification." However, it does not explicitly state the quantitative acceptance criteria for each of these tests (e.g., "burst pressure must be >X psi" or "leakage <Y ml/min") nor does it provide the specific numerical results obtained from these tests. It generally states that the device "conforms to product specification," which is the overarching acceptance criterion in this context for mechanical device validation.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only mentions "Products were tested," but does not indicate how many units of each product size were tested for each criterion.
- Data Provenance: Not applicable in the context of clinical data. These are engineering design verification and validation tests, not a clinical study involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a mechanical surgical instrument. The "ground truth" for its performance is established through physical and mechanical testing against engineering specifications, not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This refers to a method for resolving discrepancies among expert opinions in clinical studies, which is not relevant for the engineering tests described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI-assisted device. The document describes a standalone manual surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a manual surgical instrument and does not involve an algorithm. Its performance is entirely dependent on its physical properties and how it's used by a human surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering Specifications / Industry Standards. The "ground truth" for this device's performance is its adherence to predefined engineering specifications and possibly relevant industry standards for medical devices of this type. For example, balloon burst pressure would be measured against a specified minimum pressure.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is irrelevant.
In summary: The provided 510(k) summary for the Relieva Sinus Balloon Dilation Catheter demonstrates that the device's acceptance relied on internal "conformance to product specification" via engineering tests and a comparison of its "Intended Use" and "Technological Characteristics" to "marketed predicate devices" to establish substantial equivalence. It is a Class I manual surgical instrument, and its regulatory pathway does not involve the types of acceptance criteria and studies (like MRMC or standalone AI performance) typically associated with AI-driven medical devices.
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Kou35a7
2005 APR 5
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 Dilation Catheter |
| Submitter: | ExploraMed NC1, Inc.2570 West El Camino Real, Suite 310Mountain View, CA 94040Telephone: (650) 472-0300 |
| Contact: | William M. FacteauPresident & CEO |
| Date Revised: | 05 April 2005 |
Intended Use
The Relieva Sinus Balloon Dilation Catheter is intended to provide a means to dilate ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.
Device Description
The Relieva Sinus Balloon Dilation Catheter will be provided in the following balloon sizes:
- 3 mm Sinus Balloon Catheter .
- 5 mm Sinus Balloon Catheter .
- 7 mm Sinus Balloon Catheter .
The family of Relieva Sinus Balloon Dilation Catheters allows for the enlargement of sinus ostia and paranasal spaces with a minimally invasive method. The Relieva Sinus Balloon Dilation Catheters are placed in the narrow opening over a guidewire. Once positioned the balloons are inflated with a high pressure inflation device that provides feedback as to the internal pressure of the balloon. After a few seconds at the desired balloon inflation pressure, the balloon can be deflated and removed or repositioned.
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Materials
All materials used in the manufacture of the Relieva Sinus Balloon Catheter are suitable for their intended use and have been used in numerous previously cleared products.
Testing
Products were tested to ensure conformance to product specification. Testing included:
- Visual Inspection .
- Dimensional Analysis .
- Surface Finish .
- . Catheter Hub Leak
- Shaft to Hub Separation .
- Balloon Inflation Cycle Fatigue .
- Balloon Burst Pressure .
Summary of Substantial Equivalence
The Relieva Sinus Balloon Catheter is substantially equivalent to marketed predicate devices with respect to intended use and technological characteristics.
Comparison Chart of Relieva Sinus Balloon Catheter and Predicate Devices
| Relieva SinusBalloon | Circular CuttingPunch | Antrum Curette | Lacricath | |
|---|---|---|---|---|
| Manufacturer | ExploraMed NC1 | Karl StorzEndoscopy America | Karl StorzEndoscopy America | Atrion |
| 510(k) Number | K043527 | Pre-Amendments | Pre-Amendments | K935233 |
| CFR Section | 874.4420 | 874.4420 | 874.4420 | 886.4350 |
| DeviceClassification | I | I | I | I |
| Product Code | LRC | LRC | LRC | HNW |
| Intended Use | Dilation of tissue | Dilation of tissue | Dilation of tissue | Dilation of tissue |
| Working Diameter | 3mm, 5mm, 7mm | 4.5mm | 5mm | 3mm, 5mm |
| Working Length | 30cm | 18cm | 19cm | 20cm |
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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of a bird or abstract shape, composed of three curved lines that resemble wings or feathers.
APR 5 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ExploraMed II, Inc. c/o William M. Facteau President & CEO 2570 W. El Camino Real Suite 310 Mountain View, CA 94040
Re: K043527
Trade/Device Name: Relieva Sinus Balloon Catheter Regulation Number: 21 CFR 874.4420 Regulation Name: ENT manual surgical instrument Regulatory Class: Class I Product Code: LRC Dated: March 24, 2005 Received: March 25, 2005
Dear Mr. Facteau:
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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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), please contact the Office of Compliance at (301) 827-8910. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address 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
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INDICATIONS FOR USE
| 510(k) Number (if known): | This application |
|---|---|
| Device Name: | Relieva Sinus Balloon Dilation Catheter |
| Indications for Use: | The Relieva Sinus Balloon Dilation Catheter isintended to provide a means to dilate the sinusostia and spaces within the paranasal sinuscavities for diagnostic and therapeuticprocedures. |
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)
Kuna A. Baker
(Division Sign-Off)
Division of Ochthalmic Ear, ExploraMed NC1, Inc. Confidential Information Nose and Throat Devises
510(k) Number.
l
012
. .
§ 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.