PROVOX VEGA PUNCTURE SET

K131947 · Atos Medical AB · EWL · Oct 18, 2013 · Ear, Nose, Throat

Device Facts

• Record ID: K131947
• Device Name: PROVOX VEGA PUNCTURE SET
• Applicant: Atos Medical AB
• Product Code: EWL · Ear, Nose, Throat
• Decision Date: Oct 18, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

The Provox Vega Puncture Set is a single-use surgical kit for creating a tracheoesophageal (TE) puncture and placing a voice prosthesis. The set includes a pharynx protector, puncture needle, guidewire, and a puncture dilator preloaded with a Provox Vega voice prosthesis. Used in hospitals and sub-acute care institutions by clinicians. The clinician uses the needle to create the puncture, the guidewire and dilator to enlarge the tract, and the preloaded prosthesis is then positioned. The device facilitates voice restoration for patients who have undergone a laryngectomy. The prosthesis remains in situ for voice rehabilitation, with patient-performed cleaning. The set simplifies the procedure by integrating the puncture, dilation, and prosthesis placement steps.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and functional comparisons to predicate devices.

Technological Characteristics

Single-use kit. Components: Pharynx protector (thermoplastic), puncture needle (surgical stainless steel), guidewire (fluoroplastic), puncture dilator (thermoplastic elastomer/polypropylene), and voice prosthesis (medical grade silicone rubber/fluoroplastic). Mechanical insertion principle. Sterile.

Indications for Use

Indicated for laryngectomized patients requiring primary or secondary tracheoesophageal (TE) puncture and voice rehabilitation via an indwelling voice prosthesis. Contraindicated in patients with anatomical abnormalities hindering safe puncture or prosthesis placement (e.g., significant stenosis or fibrosis) and patients with severe trismus precluding pharyngeal wall protection during secondary puncture.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Provox® Vega™ Voice Prosthesis with SmartInserter (K090455)
• Provox Voice Prosthesis (K940638)

Submission Summary (Full Text)

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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 AB<br>Box 183<br>SE-242 22<br>Hörby Sweden | Tel - 011-46-415 198 00<br>Fax - 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 with<br>SmartInserter - (K090455)<br>Atos Medical - Provox Voice Prosthesis - (K940638) | |

#### 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,

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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:

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.

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 | Predicates<br>Provox Voice Prosthesis (K940638)<br>Provox® Vega™ Voice Prosthesis<br>with SmartInserter - (K090455) | Proposed<br>Provox® Vega™ Puncture Set |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Provox® Voice Rehabilitation<br>System (K940638) is intended for<br>use in surgical, prosthetic voice<br>restoration after total laryngectomy. | Provox® Vega™ Puncture Set is a device<br>for performing a primary or secondary<br>tracheo-esophageal (TE) puncture in<br>laryngectomized patients, with integrated<br>placement of a Provox Vega voice<br>prosthesis. |
| | The Provox® Vega Voice Prosthesis<br>(K090455) is a sterile single use<br>indwelling voice prosthesis intended<br>for voice rehabilitation after surgical<br>removal of the larynx<br>(laryngectomy). Cleaning of the<br>voice prosthesis is handled by the<br>Patient while it remains in situ. | The Provox Vega voice prosthesis is a<br>sterile single use indwelling voice<br>prosthesis intended for voice rehabilitation<br>after surgical removal of the larynx<br>(laryngectomy). Cleaning of the voice<br>prosthesis is performed by the patient while<br>it remains in situ. |
| Environment of<br>Use | Hospitals, sub-acute care institutions<br>and home | Identical |
| Patient Population | For patients who have got their<br>larynx surgically removed. | Identical |
| Contra-indications | Severe, surgically non-correctable<br>stenosis of the pharyngoesophageal<br>(PE) segment and/or<br>tracheostoma are contraindications<br>for the use of the Provox® voice<br>prosthesis.<br>Radiotheraphy doses greater than 70<br>Gy in 7 weeks increase the risk of<br>tissue necrosis in and around the<br>region of the TE-fistula. Creation of<br>a TE-fistula for prosthetic voice<br>rehabilitation is not recommended<br>under the circumstances. | Do not use the Provox Vega Puncture Set if<br>the patient has anatomical abnormalities<br>that may hinder safe puncturing of the TE<br>wall or safe voice prosthesis placement<br>(e.g., significant stenosis or significant<br>fibrosis at the puncture site) as this may<br>cause tissue damage.<br>Do not use the Provox Vega Puncture Set<br>for secondary TE puncture if the patient<br>suffers from severe trismus that precludes<br>proper protection of the pharyngeal wall.<br>Failure to protect the pharynx during<br>puncture may lead to unintended trauma of<br>the pharyngeal/esophageal tissue. |
| Comparison of components | | |
| Voice Prosthesis | The Provox Vega voice prosthesis<br>(K090455) is a sterile single use<br>indwelling voice prosthesis intended<br>for voice rehabilitation after surgical<br>removal of the larynx<br>(laryngectomy). Cleaning of the<br>voice prosthesis is performed by the<br>patient while it remains in situ. | The Provox* Vega™ Voice Prosthesis<br>included in the Provox® Vega™ Puncture<br>Set is identical in every aspect to the voice<br>prosthesis in the predicate Provox® Vega™<br>Voice Prosthesis with SmartInserter -<br>(K090455) |
| | | |
| Accessory:<br>Provox GuideWire | The accessory Provox GuideWire<br>(K940638) is a sterile single use<br>insertion device intended for<br>placement of a sterile Provox<br>indwelling Voice Prosthesis<br>after total laryngectomy (primary or<br>secondary puncture), or for<br>retrograde replacement of a sterile<br>Provox indwelling Voice Prosthesis. | The GuideWire together with the Puncture<br>Dilator and Wirelock is a modification of<br>the previously cleared accessory<br>GuideWire in predicate Provox Voice<br>Prosthesis (K940638). The accessory<br>GuideWire is also an accessory to the<br>predicate Provox® Vega™ Voice<br>Prosthesis with SmartInserter - (K090455) |
| Accessory:<br>Provox® Trocar | The accessory Provox® Trocar<br>(Exempted, Product Code KAB) is<br>an instrument for making primary<br>and secondary TE punctures. | The Puncture Needle in the Provox®<br>Vega™ Puncture Set is a modification of<br>the exempted device Provox Trocar that is<br>an instrument for performing the TE<br>puncture. |
| Accessory:<br>Provox® Pharynx<br>Protector | The accessory Provox® Pharynx<br>Protector (Exempted, Product Code<br>LRC) helps protect the pharyngeal<br>walls from accidental piercing<br>during primary TE puncture. | The Pharynx Protector in the Provox®<br>Vega™ Puncture Set is a modification of<br>the exempted device Provox Pharynx<br>Protector that is intended to help protect the<br>pharyngeal wall from accidental piercing<br>during primary TE puncture. |
| Materials;<br>Voice Prosthesis | Medical grade silicone rubber and<br>fluoroplastic.<br>Adhesive: Silicone Adhesive | Identical |
| Materials;<br>Provox GuideWire | ABS, PVC | GuideWire; pre-colored fluoroplastic<br>Puncture Dilator; thermoplastic elastomer<br>and polypropylene |
| Materials:<br>Provox® Trocar | surgical stainless steel | Puncture Needle: surgical stainless steel |
| Materials;<br>Provox® Pharynx<br>Protector | Stainless Steel, Aluminum, Silicone | Pharynx Protector : Transparent<br>thermoplastic |

## 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 [phone] or [phone] 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:

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 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