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 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. 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.

AI/ML Overview

Here's an analysis of the provided text regarding the Blom-Singer® Indwelling TEP Occluder, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a medical device, the Blom-Singer® Indwelling TEP Occluder, and references "functional equivalency tests" that demonstrate its performance. However, it does not explicitly state specific quantifiable acceptance criteria with numerical targets. Instead, it relies on demonstrating equivalence to predicate devices by meeting their established performance characteristics.

The "reported device performance" is a qualitative statement of equivalency rather than measured individual performance metrics against predefined criteria.

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Fistula Maintenance and Leakage Prevention: Device should maintain the TE puncture and prevent leakage of liquids from the esophagus into the trachea.	The device provides fistula maintenance while preventing leakage of liquids from the esophagus into the trachea after total laryngectomy. Functional equivalency tests demonstrated the equivalency of device performance with the three designs (including predicate devices).
Pressure Decay: Performance regarding pressure decay should be equivalent to predicate devices.	Non-clinical tests, including Pressure Decay, were performed. The conclusions drawn from these tests demonstrate that the device is safe, as effective, and performs as well or better than the predicate devices. (Specific performance values or equivalence margins are not provided).
Flange Retention Force: Performance regarding flange retention force should be equivalent to predicate devices.	Non-clinical tests, including Flange Retention Force, were performed. The conclusions drawn from these tests demonstrate that the device is safe, as effective, and performs as well or better than the predicate devices. (Specific performance values or equivalence margins are not provided).
Gel Cap Insertion Method: The gel cap insertion system should facilitate placement effectively and be equivalent to predicate devices.	Non-clinical tests, including Gel cap Insertion method, were performed. The conclusions drawn from these tests demonstrate that the device is safe, as effective, and performs as well or better than the predicate devices. The gel cap insertion system facilitates placement. (Specific performance values or equivalence margins are not provided).
Biocompatibility/Material Safety: Device should be made from safe, medical-grade materials.	Manufactured from medical grade silicone and are latex-free. Predicate devices are also manufactured from medical grade silicone and latex-free.

2. Sample Sizes Used for the Test Set and Data Provenance

The text describes "non-clinical tests" (Pressure Decay, Flange Retention Force, and Gel Cap Insertion method).

Sample Size: The document does not specify the sample sizes used for these non-clinical tests.
Data Provenance: The document does not provide information on the country of origin of the data, nor does it specify if the data was retrospective or prospective. Given these are "non-clinical tests," they likely involved laboratory testing of the devices themselves rather than patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not provided in the document. As the tests were non-clinical, they likely involved engineers or technicians conducting laboratory measurements, rather than clinical experts establishing ground truth in a diagnostic context.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the non-clinical nature of the tests, an adjudication method for human interpretation (like 2+1 or 3+1) is not applicable. The tests likely involved direct measurement and comparison to established specifications or predicate device performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done. The application describes non-clinical, functional equivalency tests comparing the device to predicate devices, not a study evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study in the context of an algorithm's performance was not done. This device is a physical medical device, not an AI algorithm. The performance described relates to its physical and functional properties.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests appears to be established performance characteristics of the predicate devices and general safety/effectiveness standards for similar medical devices. The tests aimed to demonstrate that the new device's performance was "as well or better than the predicate devices" for the specific functional attributes (Pressure Decay, Flange Retention Force, Gel Cap Insertion method). This is a form of engineering or functional validation against existing benchmarks.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is a physical medical component, not an AI model that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and therefore not provided. This device is a physical medical component, not an AI model.

Summary

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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

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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:

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

K093258

Daniel C. Clapper

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K093258

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.