(113 days)
Not Found
No
The device description details a set of physical tools and a voice prosthesis for a surgical procedure and subsequent voice rehabilitation. There is no mention of software, algorithms, data processing, or any other components typically associated with AI/ML. The description focuses on the materials and function of the physical components.
Yes
The Provox Vega voice prosthesis is explicitly described as being "intended for voice rehabilitation after surgical removal of the larynx," which is a therapeutic purpose.
No.
The device is described as a set for performing a tracheoesophageal puncture and placing a voice prosthesis, which is a therapeutic and rehabilitative function, not a diagnostic one.
No
The device description explicitly lists multiple physical components made of materials like stainless steel, thermoplastic, and silicone rubber, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for performing a surgical procedure (creating a tracheoesophageal puncture) and providing a medical device (voice prosthesis) for voice rehabilitation. This is a therapeutic and surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device components are instruments and implants used in a surgical procedure and for ongoing patient care (cleaning brushes, plug). They are not reagents, instruments, or systems intended for use in the examination of specimens derived from the human body to provide information for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information about a patient's condition.
Therefore, the Provox® Vega™ Puncture Set and Voice Prosthesis fall under the category of surgical and implantable medical devices, not In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EWL
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,
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tracheoesophageal (TE) puncture site, pharyngeal wall, pharyngoesophageal (PE) segment, tracheostoma
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospitals, sub-acute care institutions and home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Provox® Vega™ Puncture Set
K131947
Non Confidential Summary
7 October 2013 Page 1 of 4
Section 5 - 510(k) Summary
| Atos Medical AB
Box 183
SE-242 22
Hörby Sweden | Tel - 011-46-415 198 00
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
SmartInserter - (K090455)
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,
1
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.
2
.
Non Confidential Summary
7 October 2013 Page 3 of 4
| Specification | Predicates
Provox Voice Prosthesis (K940638)
Provox® Vega™ Voice Prosthesis
with SmartInserter - (K090455) | Proposed
Provox® Vega™ Puncture Set |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Provox® Voice Rehabilitation
System (K940638) is intended for
use in surgical, prosthetic voice
restoration after total laryngectomy. | Provox® Vega™ Puncture Set is a device
for performing a primary or secondary
tracheo-esophageal (TE) puncture in
laryngectomized patients, with integrated
placement of a Provox Vega voice
prosthesis. |
| | The Provox® Vega Voice Prosthesis
(K090455) 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 handled by the
Patient while it remains in situ. | 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. |
| Environment of
Use | Hospitals, sub-acute care institutions
and home | Identical |
| Patient Population | For patients who have got their
larynx surgically removed. | Identical |
| Contra-indications | Severe, surgically non-correctable
stenosis of the pharyngoesophageal
(PE) segment and/or
tracheostoma are contraindications
for the use of the Provox® voice
prosthesis.
Radiotheraphy doses greater than 70
Gy in 7 weeks increase the risk of
tissue necrosis in and around the
region of the TE-fistula. Creation of
a TE-fistula for prosthetic voice
rehabilitation is not recommended
under the circumstances. | 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 pharyngeal wall.
Failure to protect the pharynx during
puncture may lead to unintended trauma of
the pharyngeal/esophageal tissue. |
| Comparison of components | | |
| Voice Prosthesis | The Provox Vega voice prosthesis
(K090455) 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. | The Provox* Vega™ Voice Prosthesis
included in the Provox® Vega™ Puncture
Set is identical in every aspect to the voice
prosthesis in the predicate Provox® Vega™
Voice Prosthesis with SmartInserter -
(K090455) |
| | | |
| Accessory:
Provox GuideWire | The accessory Provox GuideWire
(K940638) is a sterile single use
insertion device intended for
placement of a sterile Provox
indwelling Voice Prosthesis
after total laryngectomy (primary or
secondary puncture), or for
retrograde replacement of a sterile
Provox indwelling Voice Prosthesis. | The GuideWire together with the Puncture
Dilator and Wirelock is a modification of
the previously cleared accessory
GuideWire in predicate Provox Voice
Prosthesis (K940638). The accessory
GuideWire is also an accessory to the
predicate Provox® Vega™ Voice
Prosthesis with SmartInserter - (K090455) |
| Accessory:
Provox® Trocar | The accessory Provox® Trocar
(Exempted, Product Code KAB) is
an instrument for making primary
and secondary TE punctures. | The Puncture Needle in the Provox®
Vega™ Puncture Set is a modification of
the exempted device Provox Trocar that is
an instrument for performing the TE
puncture. |
| Accessory:
Provox® Pharynx
Protector | The accessory Provox® Pharynx
Protector (Exempted, Product Code
LRC) helps protect the pharyngeal
walls from accidental piercing
during primary TE puncture. | The Pharynx Protector in the Provox®
Vega™ Puncture Set is a modification of
the exempted device Provox Pharynx
Protector that is intended to help protect the
pharyngeal wall from accidental piercing
during primary TE puncture. |
| Materials;
Voice Prosthesis | Medical grade silicone rubber and
fluoroplastic.
Adhesive: Silicone Adhesive | Identical |
| Materials;
Provox GuideWire | ABS, PVC | GuideWire; pre-colored fluoroplastic
Puncture Dilator; thermoplastic elastomer
and polypropylene |
| Materials:
Provox® Trocar | surgical stainless steel | Puncture Needle: surgical stainless steel |
| Materials;
Provox® Pharynx
Protector | Stainless Steel, Aluminum, Silicone | Pharynx Protector : Transparent
thermoplastic |
Summary of substantial equivalence
.
3
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.
4
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.
5
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
6
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