(49 days)
The Blom-Singer Indwelling 2000 Voice Prosthesis is for voice rehabilitation following total laryngectomy where placement/replacement of the voice prosthesis is done by a clinician. The Blom-Singer Indwelling 2000 Voice Prosthesis may be placed at the time of surgery or may be placed at a later date secondary to the laryngectomy.
The design of the Blom-Singer Indwelling 2000 Voice Prosthesis is substantially equivalent to the current Blom-Singer Indwelling Low Pressure Voice Prosthesis. Both devices are manufactured sterile and nonsterile, out of medical grade silicone elastomer, and are comprised of a body with an outer esophageal flange and a tracheal flange with a strap. Both devices utilize a flap valve to control the passage of air through the device. The Blom-Singer Indwelling 2000 has the addition of an assembled cartridge, consisting of a valve seat, to optimize the valve performance and longevity. The valve now has an additive which has demonstrated antibacterial properties in in-vitro studies. To aid in placing the gel cap onto the device, the esophageal flange on the outer portion of the device has been modified. The esophageal flange now has contoured areas, which allow the flange to fold along the contours for easy insertion into a gel cap for atraumatic placement of the device.
The provided text is a 510(k) summary for a medical device called the "Blom-Singer Indwelling 2000 Voice Prosthesis." It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain a study or data proving the device meets specific acceptance criteria.
The document states that "Functional equivalency tests have been performed on the two Blom-Singer prostheses, which demonstrate the equivalency of the valve performance with the two designs." However, it does not provide any details about these tests, such as:
- Specific acceptance criteria: What metrics were used to define "equivalency of valve performance"? What were the thresholds for acceptance?
- Reported device performance: What were the results of these tests?
- Study design: What type of study was this? How many devices were tested? What was the methodology?
- Sample size and data provenance: How many devices were in the test set? Where did the data come from?
- Ground truth establishment: How was the "true" valve performance determined for comparison?
- Adjudication method, MRMC studies, or standalone performance: These concepts are not applicable to the type of "functional equivalency tests" alluded to for a device like this, which focuses on mechanical performance rather than diagnostic accuracy.
- Training set sample size and ground truth establishment: Not applicable as this is a mechanical device, not an AI/algorithm-based diagnostic tool.
Therefore, I cannot provide the requested table and detailed study information because the input document does not contain this specific data.
Here's what I can extract based on the available information:
1. Acceptance Criteria and Reported Device Performance:
The document states that "Functional equivalency tests have been performed on the two Blom-Singer prostheses, which demonstrate the equivalency of the valve performance with the two designs." This implies that the acceptance criterion was "equivalency of valve performance" between the new device and its predicate. However, no specific quantitative criteria or reported performance metrics are provided.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalency of valve performance with predicate device | Demonstrated equivalency (no specific quantitative data provided) |
| Antibacterial properties (in-vitro studies) | Demonstrated antibacterial properties (no specific quantitative data provided) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified.
- Data Provenance: The document only mentions "in-vitro studies" for antibacterial properties and "functional equivalency tests." No information is provided about the country of origin or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or specified. The "functional equivalency tests" would likely involve objective measurements of physical properties, not expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or specified.
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: Not applicable. This is a medical device (voice prosthesis), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the "functional equivalency tests," the ground truth would likely be established through objective physical measurements and engineering specifications, not expert consensus or clinical outcomes in the typical sense for diagnostic devices. No explicit details are given.
8. The sample size for the training set: Not applicable. This is a mechanical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document focuses on establishing substantial equivalence for regulatory purposes based on design, materials, and intended use, rather than presenting detailed performance study data with specific acceptance criteria.
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HELIX MEDICAL, INC 510(k) SUMMARY BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS
I. NAME OF SUBMITTER
Helix Medical, Inc. 1110 Mark Avenue Carpinteria, CA 93013 Contact person: Cynthia Anderson
Establishment Registration Number: 2025182
II. DEVICE NAME AND CLASSIFICATION
Proprietary Name: Blom-Singer Indwelling 2000 Voice Prosthesis Voice Prosthesis Common or Usual Name:
Class II: 21 CFR 874.3730 The Blom-Singer Indwelling 2000 Voice Prosthesis is neither a life-supporting nor a lifesustaining device. It is not considered an implant.
III. PREDICATE DEVICES
The Blom-Singer Indwelling 2000 Voice Prosthesis and its accessory devices are substantially equivalent in design and indications for use to the following devices currently in commercial distribution:
· InHealth Indwelling Voice Prosthesis, Helix Medical, Carpinteria, CA; K932120
· Provox2 Voice Rehabilitation System, ATOS Medical AB, Hörby, Sweden; K971244
The Blom-Singer Indwelling 2000 Voice Prosthesis Accessory Devices are either Class I devices not subject to 510(k) or are substantially equivalent to the following devices:
· InHealth Blom-Singer Low Pressure Voice Prosthesis Gel Cap Insertion System. Helix Medical, Carpinteria, CA; K930105 (Inserter Tool and Gel Caps)
· InHealth Blom-Singer Flushing Pipet, Helix Medical, Carpinteria, CA; K932163 (Flushing Device)
· InHealth Blom-Singer Indwelling Plug Insert Accessory Device, Helix Medical, Carpinteria, CA; K945288 (Plug Insert)
IV. DESCRIPTION
The design of the Blom-Singer Indwelling 2000 Voice Prosthesis is substantially equivalent to the current Blom-Singer Indwelling Low Pressure Voice Prosthesis. Both devices are
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manufactured sterile and nonsterile, out of medical grade silicone elastomer, and are comprised of a body with an outer esophageal flange and a tracheal flange with a strap. Both devices utilize a flap valve to control the passage of air through the device. The Blom-Singer Indwelling 2000 has the addition of an assembled cartridge, consisting of a valve seat, to optimize the valve performance and longevity. The valve now has an additive which has demonstrated antibacterial properties in in-vitro studies.
To aid in placing the gel cap onto the device, the esophageal flange on the outer portion of the device has been modified. The esophageal flange now has contoured areas, which allow the flange to fold along the contours for easy insertion into a gel cap for atraumatic placement of the device.
V. INTENDED USE
The Blom-Singer Indwelling 2000 Voice Prosthesis is for voice rehabilitation following total laryngectomy where placement of the voice prosthesis is done by a clinician.
The Blom-Singer Indwelling 2000 Voice Prosthesis may be placed at the time of surgery or may be placed at a later date secondary to the laryngectomy.
VI. TECHNOLOGICAL CHARACTERISTICS
The Blom-Singer Indwelling 2000 Voice Prosthesis is provided for the same indications for use as its predicate devices, the Blom-Singer Indwelling Low Pressure Voice Prosthesis and the Provox 2 Voice Prosthesis. All three devices are indwelling devices designed to provide voicing after total laryngectomy. The devices are placed in a surgically-created fistula between the trachea and esophagus in order to divert air through the prosthesis valve to created 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.
The Blom-Singer Indwelling 2000 Voice Prosthesis has been modified from its predicate device by the addition of the assembled cartridge, consisting of a valve and valve seat, to isolate the valve and valve seat from tissue contact. The valve has an antibacterial additive.
Functional equivalency tests have been performed on the two Blom-Singer prostheses, which demonstrate the equivalency of the valve performance with the two designs.
Accessory Devices: The Blom-Singer Indwelling 2000 Voice Prosthesis will be offered with the following accessories as optional items:
The Inserter Tool and Gel Caps
Blom-Singer Flushing Device.
Blom-Singer Brush
Blom-Singer Plug Insert .
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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 5 1999
Ms. Cynthia Anderson Director, Regulatory Affairs/Quality Assurance Helix Medical, Inc. 11100 Mark Avenue Carpinteria, CA 93013
Re: K991587 Trade Name: Blom-Singer Indwelling 2000 Voice Prosthesis Regulatory Class: II Product Code: 77 EWL Dated: May 6, 1999 Received: May 7, 1999
Dear Ms. Anderson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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Page 2 - Ms. Cynthia Anderson
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on.the.promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Include the following "Indications For Use" page that contains the applicant's name, name of the device and the intended use of the device. The information, data and labeling claims in the entire the 510(k) submission must support and agree with the "indications for use" statement.
*For a new submission, do NOT fill in the 510(k) number blank.
INDICATIONS FOR USE
Applicant: Helix Medical, Inc.
510(k) Number (if known): N/A * CP/1587
Device Name: Blom-Singer Indwelling 2000 Voice Prosthesis.
Indications For Use:
The Blom-Singer Indwelling 2000 Voice Prosthesis is for voice rehabilitation following total laryngectomy where placement/replacement of the voice prosthesis is done by a clinician. The Blom-Singer Indwelling 2000 Voice Prosthesis may be placed at the time of surgery or may be placed at a later date secondary to the laryngectomy.
(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 CFR 801.109
OR
Over-the-Counter
Kuen H. Bahr
(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number.
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§ 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.