The Blom-Singer Indwelling voice prosthesis is indicated for tracheoesophageal voice restoration following total laryngectomy, when placement, or replacement, of an indwelling voice prosthesis is performed by a qualified, trained medical professonal.

Device Description

The Blom-Singer Dual Valve Indwelling Voice Prosthesis is provided for the same indications for use as the other Blom-Singer Indwelling Voice Prosthesis product lines. The Dual Valve Indwelling Voice Prosthesis has been modified from its predicate devices by the addition of a second valve intended to continue to function when leakage occurs in the primary valve.

The Blom-Singer Dual Valve Indwelling Prosthesis has been modified from its predicate devices by the addition of a second valve, consisting of a valve and valve seat, intended to continue to function when leakage occurs in the primary valve. The prosthesis is still primarily silicone. A second modification is the introduction of a slight tension in the voice prosthesis strap when loaded on the inserter with a gel cap containing the prosthesis' esophageal flange. When the gel cap dissolves the inserter moves forward, indicating flange deployment.

Accessory Devices: The device will be offered with the following accessories: inserter stick, flushing device, flange introducer, gel caps, and lubricant,

AI/ML Overview

The provided document is a 510(k) summary for the Blom-Singer Dual Valve Voice Prosthesis. It does not contain information typically found in a study proving a device meets acceptance criteria, such as a detailed clinical study with specific acceptance criteria, sample sizes, expert involvement, or statistical analysis.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices through non-clinical functional equivalency tests.

Here's a breakdown of the requested information based on the provided text, and where the information is not available:

Acceptance Criteria and Device Performance Study Details (Blom-Singer Dual Valve Voice Prosthesis)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from predicate devices)	Reported Device Performance (Blom-Singer Dual Valve Voice Prosthesis)
Functioning of primary valve for voicing	The device includes a "second valve intended to continue to function when leakage occurs in the primary valve," implying improved sustained function related to leakage compared to predicate devices which presumably had only one valve. Implicitly performs at least as well as the predicate's single valve function, with the added benefit of the secondary valve.
Airflow characteristics	"Functional equivalency tests have been performed on the Blom-Singer prostheses, which demonstrate the equivalency of the valve performance with the predicate designs." Specifically, "Non-clinical tests referenced for a determination of substantial equivalence are Airflow..."
Pressure Decay characteristics	"Functional equivalency tests have been performed on the Blom-Singer prostheses, which demonstrate the equivalency of the valve performance with the predicate designs." Specifically, "...Pressure Decay..."
Flange Retention Force	"Functional equivalency tests have been performed on the Blom-Singer prostheses, which demonstrate the equivalency of the valve performance with the predicate designs." Specifically, "...Flange Retention Force..."
Valve Attachment Integrity	"Functional equivalency tests have been performed on the Blom-Singer prostheses, which demonstrate the equivalency of the valve performance with the predicate designs." Specifically, "...Valve Attachment Integrity..."
Inserter Deployment	"Functional equivalency tests have been performed on the Blom-Singer prostheses, which demonstrate the equivalency of the valve performance with the predicate designs." Specifically, "...Inserter Deployment." Additionally, a modification involving "slight tension in the voice prosthesis strap when loaded on the inserter with a gel cap" is described, indicating a design change to aid deployment.

Summary of Device Performance: The document explicitly states: "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."

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. The document mentions "nonclinical tests" and "functional equivalency tests" but does not provide any numerical sample sizes for these tests.
Data Provenance (Country of origin, retrospective/prospective): Not specified. These were likely bench tests conducted by the manufacturer, Helix Medical, LLC, which is based in Carpinteria, CA, USA. The nature of the tests (non-clinical) implies they are not human clinical data, and thus the terms "retrospective" or "prospective" as applied to clinical studies are not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the document describes non-clinical, functional equivalency bench tests, not a clinical study requiring expert-established ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable as the document describes non-clinical, functional equivalency bench tests, not a clinical study requiring adjudication.

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

This information is not applicable. The device is a voice prosthesis, not an AI or imaging diagnostic tool that would involve human readers or MRMC studies.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical medical device (voice prosthesis), not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical functional equivalency tests would be established by engineering specifications and performance metrics derived from the predicate devices. The tests aimed to show that the new device's performance in specific areas (Airflow, Pressure Decay, Flange Retention Force, Valve Attachment Integrity, Inserter Deployment) was "equivalent" to the predicate devices.

8. The sample size for the training set

This information is not applicable. The document describes the submission of a physical medical device, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable. As above, the device is not a machine learning model.

Summary

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K08 2206

Image /page/0/Picture/1 description: The image shows the logo for Helix Medical. The word "HELIX" is written in large, bold, black letters with horizontal lines running through each letter. Below "HELIX" is the word "MEDICAL" written in smaller, black letters. The logo has a simple and professional design.

SEP - 4 2008

Helix Medical, LLC 510(k) Summary Blom-Singer Dual Valve Voice Prosthesis

I NAME OF SUBMITTER

Helix Medical, LLC 1110 Mark Ave. Carpinteria, CA 93013 Contact Person: Cynthia Anderson Establishment Registration Number: 2025182

II DEVICE NAME AND CLASSIFICATION

Proprietary Name: Blom-Singer Dual Valve Voice Prosthesis Common or Usual Name: Voice Prosthesis

Class II, 21 CFR 874.3730 The Blom-Singer Dual Valve Voice Prosthesis 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

K945287, InHealth Blom-Singer Indwelling Valved Insert, December 9, 1994

K991587, Blom-Singer Indwelling 2000, June 25, 1999

Related accessories being provided with product:

-inserter stick -flushing device -flange introducer -gel caps -lubricant

IV DESCRIPTION

Helix Medical, LLC ● 1110 Mark Avenue ● Carpinteria, CA 93013 USA Tel: (805)684-3304 ● Toll-Free: (800)266-4421 ● Fax: (805)684-1934 www.helixmedical.com

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Image /page/1/Picture/0 description: The image shows the logo for Helix Medical. The word "HELIX" is written in large, bold, black letters with horizontal lines running through them. Below the word "HELIX" is the word "MEDICAL" written in smaller, sans-serif letters. The logo has a simple and clean design.

510(k) Summary cont'd.

V INTENDED USE

VI TECHNOLOGICAL REQUIREMENTS

The Blom-Singer Dual Valve Indwelling Voice Prosthesis is provided for the same indications for use as its predicate devices, the Blom-Singer Indwelling 2000 Voice Prosthesis, the Blom-Singer Indwelling Low Pressure Voice Prosthesis, and the InHealth Blom-Singer Indwelling Valved Insert. All three devices are indwelling devices primarily made of silicone, designed to provide voicing after total laryngectomy. The voice prostheses are placed in a surgically-created fistula between the trachea and esophagus in order to divert air through the prosthesis valve to create voicing. The use of an indwelling device means that routine removal for cleaning by the patient is not necessary, thus making it easier for the patient to maintain the device while reducing the risk of accidental dislodgment of the device.

Functional equivalency tests have been performed on the Blom-Singer prostheses, which demonstrate the equivalency of the valve performance with the predicate designs. Non-clinical tests referenced for a determination of substantial equivalence are Airflow, Pressure Decay, Flange Retention Force, Valve Attachment Integrity and Inserter Deployment. 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: The device will be offered with the following accessories: inserter stick, flushing device, flange introducer, gel caps, and lubricant,

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 4 2008

Helix Medical, LLC c/o Ms. Cynthia Anderson VP, Regulatory Affairs 1110 Mark Avenue Capinteria, CA 93013

Re: K082206

Trade/Device Name: Blom-Singer Dual Valve Voice Prosthesis Regulation Number: 21 CFR 874.3730 Regulation Name: Laryngeal prosthesis (Taub design) Regulatory Class: Class II Product Code: EWL Dated: July 31, 2008 Received: August 5, 2008

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.

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 Center for Devices and Radiological Health's (CDRH)'s) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Malvina B. Egleston, und

Malvina B. Eydelman, M.I 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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K082206

Indications for Use Statement

510(k) Number: not yet assigned K682QOC

Device Name: Blom-Singer Dual Valve Voice Prosthesis

Indications for Use:

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)

Over-The-Counter Use

Daniel C. Cligg

510(k) Number K082206

Regulation Number and Section

§ 874.3730 Laryngeal prosthesis (Taub design).

(a)
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.(b)
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.