Provox® Vega™ Puncture Set is a device for performing a primary or secondary tracheoesophageal (TE) puncture in laryngectomized patients, with integrated placement of a Provox Vega voice prosthesis.

The Provox Vega voice prosthesis is a sterile single use indwelling voice prosthesis intended for voice rehabilitation after surgical removal of the larynx (laryngectomy). Cleaning of the voice prosthesis is performed by the patient while it remains in situ.

Environments of use include;

Provox® VegaTM Puncture Set hospitals and sub-acute care institutions.
Provox® Vega Voice Prosthesis hospitals, sub-acute care institutions and home.

Device Description

The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture, with subsequent dilatation of that puncture to a width that facilitates placement of the included Provox Vega voice prosthesis. The Provox Vega voice prosthesis is preloaded on the Puncture Dilator, which is part of the device.

The Provox Vega Puncture Set is intended for single use only and the package contains the following sterile items in a blister package:

· 1 Pharynx Protector (Fig. 1:1) made of transparent thermoplastic,
· 1 Puncture Needle (Fig. 1.2) made of surgical stainless steel.
· 1 Guidewire (Fig. 1.3) made of pre-colored fluoroplastic.
· I Puncture Dilator with I preloaded Provox Vega voice prosthesis (Fig. 1.4). The Puncture Dilator is made of thermoplastic elastomer and polypropylene; and the Vega voice prosthesis is made of medical grade silicone rubber and fluoroplastic.

The set also includes the following non-sterile items:

· 1 Instructions for use Provox Vega Puncture Set,
· 1 Provox Vega Patient's Manual,
· 1 Provox Brush of a size corresponding to the voice prosthesis,
· 1 Provox Brush Instructions for Use.
· I Provox Plug of a size corresponding to the voice prosthesis,
· 1 Provox Plug Instructions for Use.
· 1 Emergency Card

AI/ML Overview

The provided text describes the Provox® Vega™ Puncture Set and compares it to predicate devices to establish substantial equivalence. However, it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through empirical testing.

The submission focuses on demonstrating that the proposed device is as safe and effective, and performs as well or better than the predicate devices based on:

Identical indications for use (for the voice prosthesis component)
Similar materials
Similar design
Similar operating principles

Essentially, the argument for equivalence is based on the lack of significant differences in these aspects between the new device and previously cleared devices, rather than a standalone performance study with predefined acceptance criteria.

Therefore, many of the requested sections about acceptance criteria, reported performance, sample sizes, ground truth, expert adjudication, or MRMC studies cannot be extracted from this document because such a study is not detailed.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document does not specify quantitative acceptance criteria or report performance metrics from a formal study. The conclusion is based on substantial equivalence to predicate devices, implying that if the predicate devices meet their acceptance criteria, the new device will too due to its similarity.

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

Cannot be provided. No specific test set or study involving human subjects or data is described. The comparison is primarily regulatory and technical, based on device specifications and intended use.

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

Cannot be provided. No ground truth establishment activity is mentioned for a test set.

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

Cannot be provided. No test set or adjudication process is 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

Cannot be provided. This device is a medical instrument (voice prosthesis and puncture set), not an AI/imaging device. Therefore, MRMC studies or AI improvement metrics are not relevant or discussed.

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

Cannot be provided. Not applicable as this is not an algorithm/AI device.

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

Cannot be provided. No ground truth is established for a performance study. "Ground truth" here is effectively the accepted safety and effectiveness of the predicate devices.

8. The sample size for the training set

Cannot be provided. Not applicable as this is not an algorithm/AI device that requires a training set.

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

Cannot be provided. Not applicable.

Summary of Substantial Equivalence Information (relevant to the document's purpose):

The document aims to demonstrate substantial equivalence to predicate devices rather than report on a new performance study with explicit acceptance criteria.

Predicate Devices:
- Atos Medical - Provox® Vega™ Voice Prosthesis with SmartInserter - (K090455)
- Atos Medical - Provox Voice Prosthesis - (K940638)
Basis for Equivalence:
- Indications for Use: The Provox Vega Puncture Set's voice prosthesis component has identical indications to the predicate Provox® Vega™ Voice Prosthesis (K090455). The puncture set's overall function is for performing TE puncture with integrated placement of the voice prosthesis.
- Materials: Stated as "Identical" for the Voice Prosthesis (medical grade silicone rubber and fluoroplastic) compared to the predicate Vega voice prosthesis. Components like the Guidewire, Puncture Needle, and Pharynx Protector are described as "modifications" of previously cleared or exempted accessories from predicate devices, with materials like pre-colored fluoroplastic, thermoplastic elastomer, surgical stainless steel, and transparent thermoplastic.
- Design: The Provox Vega™ Voice Prosthesis included in the Puncture Set is stated to be "identical in every aspect" to the voice prosthesis in the predicate K090455. Other components are modifications of existing accessories.
- Operating Principles: Not explicitly elaborated in detail beyond component function but implied to be similar due to comparable design and intended use.

The conclusion by Atos Medical AB is that "There are no significant differences between the Provox Vega Puncture Set compared to the predicate devices in terms of indications, materials, design and operating principles. Information presented in this submission supports that Provox Vega Puncture Set is as safe and effective, and performs as well or better than the predicate devices." This is the core "proof" presented for regulatory acceptance.

Summary

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Provox® Vega™ Puncture Set

K131947

Non Confidential Summary

7 October 2013 Page 1 of 4

Section 5 - 510(k) Summary

Atos Medical ABBox 183SE-242 22Hörby Sweden	Tel - 011-46-415 198 00Fax - 011-46-415 198 98	OCT 18 2013
Official Contact:	Ferenc Dahnér - Regulatory Affairs Manager
Proprietary or Trade Name:	Provox® Vega™ Puncture Set
Common/Usual Name:	Voice Prosthesis
Classification	Class II - 21 CFR 874:3730
Classification Name/Code:	Prosthesis, Laryngeal (Taub) / EWL
Device:	Provox® Vega™ Puncture Set
Predicate Devices:	Atos Medical - Provox® Vega™ Voice Prosthesis withSmartInserter - (K090455)Atos Medical - Provox Voice Prosthesis - (K940638)

Device Description:

The Provox Vega Puncture Set is intended for single use only and the package contains the following sterile items in a blister package:

· 1 Pharynx Protector (Fig. 1:1) made of transparent thermoplastic,
· 1 Puncture Needle (Fig. 1.2) made of surgical stainless steel.
· 1 Guidewire (Fig. 1.3) made of pre-colored fluoroplastic.
· I Puncture Dilator with I preloaded Provox Vega voice prosthesis (Fig. 1.4). The Puncture Dilator is made of thermoplastic elastomer and polypropylene; and the Vega voice prosthesis is made of medical grade silicone rubber and fluoroplastic.

The set also includes the following non-sterile items:

· 1 Instructions for use Provox Vega Puncture Set,
· 1 Provox Vega Patient's Manual,
· 1 Provox Brush of a size corresponding to the voice prosthesis,
· 1 Provox Brush Instructions for Use.
· I Provox Plug of a size corresponding to the voice prosthesis,

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Non Confidential Summary

7 October 2013 Page 2 of 4

· 1 Provox Plug Instructions for Use. · 1 Emergency Card

Indications for Use:

The Provox Vega voice prosthesis is a sterile single use indwelling voice prosthesis intended for voice rehabilitation after surgical removal of the larynx (laryngectomy), Cleaning of the voice prosthesis is performed by the patient while it remains in situ.

Environments of use include;

Provox® VegaTM Puncture Set hospitals and sub-acute care institutions.
Provox® Vega Voice Prosthesis hospitals, sub-acute care institutions and home.

Patient Population: For patients who have got their larynx surgically removed.

Environment of Use:

Provox® Vega™ Puncture Set - hospitals and sub-acute care institutions.
Provox® Vega Voice Prosthesis hospitals, sub-acute care institutions and home.
Contraindications: Do not use the Provox Vega Puncture Set if the patient has anatomical abnormalities that may hinder safe puncturing of the TE wall or safe voice prosthesis placement (e.g., significant stenosis or significant fibrosis at the puncture site) as this may cause tissue damage.

Do not use the Provox Vega Puncture Set for secondary TE puncture if the patient suffers from severe trismus that precludes proper protection of the pharvngeal wall. Failure to protect the pharynx during puncture may lead to unintended trauma of the pharyngeal/esophageal tissue.

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Non Confidential Summary

7 October 2013 Page 3 of 4

Specification	PredicatesProvox Voice Prosthesis (K940638)Provox® Vega™ Voice Prosthesiswith SmartInserter - (K090455)	ProposedProvox® Vega™ Puncture Set
Indications for use	The Provox® Voice RehabilitationSystem (K940638) is intended foruse in surgical, prosthetic voicerestoration after total laryngectomy.	Provox® Vega™ Puncture Set is a devicefor performing a primary or secondarytracheo-esophageal (TE) puncture inlaryngectomized patients, with integratedplacement of a Provox Vega voiceprosthesis.
	The Provox® Vega Voice Prosthesis(K090455) is a sterile single useindwelling voice prosthesis intendedfor voice rehabilitation after surgicalremoval of the larynx(laryngectomy). Cleaning of thevoice prosthesis is handled by thePatient while it remains in situ.	The Provox Vega voice prosthesis is asterile single use indwelling voiceprosthesis intended for voice rehabilitationafter surgical removal of the larynx(laryngectomy). Cleaning of the voiceprosthesis is performed by the patient whileit remains in situ.
Environment ofUse	Hospitals, sub-acute care institutionsand home	Identical
Patient Population	For patients who have got theirlarynx surgically removed.	Identical
Contra-indications	Severe, surgically non-correctablestenosis of the pharyngoesophageal(PE) segment and/ortracheostoma are contraindicationsfor the use of the Provox® voiceprosthesis.Radiotheraphy doses greater than 70Gy in 7 weeks increase the risk oftissue necrosis in and around theregion of the TE-fistula. Creation ofa TE-fistula for prosthetic voicerehabilitation is not recommendedunder the circumstances.	Do not use the Provox Vega Puncture Set ifthe patient has anatomical abnormalitiesthat may hinder safe puncturing of the TEwall or safe voice prosthesis placement(e.g., significant stenosis or significantfibrosis at the puncture site) as this maycause tissue damage.Do not use the Provox Vega Puncture Setfor secondary TE puncture if the patientsuffers from severe trismus that precludesproper protection of the pharyngeal wall.Failure to protect the pharynx duringpuncture may lead to unintended trauma ofthe pharyngeal/esophageal tissue.
Comparison of components
Voice Prosthesis	The Provox Vega voice prosthesis(K090455) is a sterile single useindwelling voice prosthesis intendedfor voice rehabilitation after surgicalremoval of the larynx(laryngectomy). Cleaning of thevoice prosthesis is performed by thepatient while it remains in situ.	The Provox* Vega™ Voice Prosthesisincluded in the Provox® Vega™ PunctureSet is identical in every aspect to the voiceprosthesis in the predicate Provox® Vega™Voice Prosthesis with SmartInserter -(K090455)

Accessory:Provox GuideWire	The accessory Provox GuideWire(K940638) is a sterile single useinsertion device intended forplacement of a sterile Provoxindwelling Voice Prosthesisafter total laryngectomy (primary orsecondary puncture), or forretrograde replacement of a sterileProvox indwelling Voice Prosthesis.	The GuideWire together with the PunctureDilator and Wirelock is a modification ofthe previously cleared accessoryGuideWire in predicate Provox VoiceProsthesis (K940638). The accessoryGuideWire is also an accessory to thepredicate Provox® Vega™ VoiceProsthesis with SmartInserter - (K090455)
Accessory:Provox® Trocar	The accessory Provox® Trocar(Exempted, Product Code KAB) isan instrument for making primaryand secondary TE punctures.	The Puncture Needle in the Provox®Vega™ Puncture Set is a modification ofthe exempted device Provox Trocar that isan instrument for performing the TEpuncture.
Accessory:Provox® PharynxProtector	The accessory Provox® PharynxProtector (Exempted, Product CodeLRC) helps protect the pharyngealwalls from accidental piercingduring primary TE puncture.	The Pharynx Protector in the Provox®Vega™ Puncture Set is a modification ofthe exempted device Provox PharynxProtector that is intended to help protect thepharyngeal wall from accidental piercingduring primary TE puncture.
Materials;Voice Prosthesis	Medical grade silicone rubber andfluoroplastic.Adhesive: Silicone Adhesive	Identical
Materials;Provox GuideWire	ABS, PVC	GuideWire; pre-colored fluoroplasticPuncture Dilator; thermoplastic elastomerand polypropylene
Materials:Provox® Trocar	surgical stainless steel	Puncture Needle: surgical stainless steel
Materials;Provox® PharynxProtector	Stainless Steel, Aluminum, Silicone	Pharynx Protector : Transparentthermoplastic

Summary of substantial equivalence

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Provox® Vega™ Puncture Set

Non Confidential Summary

7 October 2013 Page 4 of 4

Summary:

There are no significant differences between the Provox Vega Puncture Set compared to the predicate devices in terms of indications, materials, design and operating principles. Information presented in this submission supports that Provox Vega Puncture Set is as safe and effective, and performs as well or better than the predicate devices.

Conclusion:

Atos Medical AB concludes that the Provox Vega Puncture set is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

October 18, 2013

Atos Medical AB c/o Mr. Ferenc Dahnér Regulatory Affairs Manager PO Box 183 SE 242 22 Hörby Sweden

Re: K131947

Trade/Device Name: Provox Vega Puncture Set Regulation Number: 21 CFR 874.3730 Regulation Name: Laryngeal Prosthesis (Taub Design) Regulatory Class: Class II Product Code: EWL Dated: September 4, 2013 Received: September 6, 2013

Dear Mr. Dahner:

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 - Mr. Ferenc Dahnér

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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kesia Y. Alexander -S

for 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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Indications for Use

Page 1 of 1.

K131947 510(k) Number:

Provox® Vega™ Puncture Set Device Name:

Indications for Use:

Environments of use include;

Provox Vega Puncture Set Hospitals
Provox Vega Voice Prosthesis Hospitals, sub-acute care institutions and home.

Prescription Use XX (Part 21 CFR 801 Subpart D) and/or

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Srinivas
Nandkumar -S

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.