(279 days)
Not Found
No
The description focuses on hardware components, software control for pressure and timing, and standard input/output methods. There is no mention of learning, adaptation, or complex pattern recognition typically associated with AI/ML.
No
The device is described as a diagnostic tool used to elicit and measure the laryngeal closure reflex, not to treat a condition.
Yes
The device is intended to "measure the sensory discrimination threshold at which the reflex occurs" which is a diagnostic purpose.
No
The device description explicitly states that the device contains an Air Pump and the mechanics to control the pressure of an air pulse, in addition to being software controlled. This indicates the presence of hardware components beyond just software.
Based on the provided information, the AP-4000, Air Pulse Sensory Stimulator, is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- AP-4000 Function: The AP-4000 directly stimulates structures within the human body (Upper Airway) to elicit a physiological reflex (Laryngeal Closure Reflex/Swallow) and measure a sensory threshold. It does not examine specimens derived from the body.
- Method of Use: The device is used in conjunction with an endoscope introduced into the patient's body.
Therefore, the AP-4000 is a medical device used for in vivo stimulation and measurement, not an in vitro examination of specimens.
N/A
Intended Use / Indications for Use
The AP-4000, Air Pulse Sensory Stimulator, is intended to elicit Laryngeal Closure Reflex (Swallow) and to measure the sensory discrimination threshold at which the reflex occurs in the area of the Upper Airway innervated by the Superior Laryngeal Nerve. The structures being stimulated in the area of the Upper Airway innervated by the Superior Laryngeal Nerve are: the Left and Right Anterior Wall of the Pyriform Sinus and the Left and Right Aryepiglottic Folds. The device is intended to be used with the Pentax FNL-10AP or FNL-10RAP, Fiber Naso -Pharyngo- Laryngo Scope, introduced per nasally in Adult and Pediatric patient populations with suspected Dysphagia.
Product codes
LLN
Device Description
The AP-4000, Air Pulse Sensory Stimulator, is an endoscopic accessory that must be used with the Pentax FNL-10AP or FNL-10RAP, Fiber Naso-Pharyngo-(Laryngo) Scopes. The AP-4000 is a software controlled device. The device contains an Air Pump and the mechanics to control the pressure of a 50 millisecond (ms) air pulse, delivered through the FNL-10AP working channel. The device is connected to the endoscope working channel with an Air Supply Tube (two pieces are included with the device as standard set components). The device front panel has controls and displays to allow a desired pressure for the 50 ms air pulse to be selected (in the range 2 mm Hg to 10 mm Hg), the air pulse to be initiated, and the actual pressure of the delivered air pulse to be displayed. There are connections for the Air Supply Tube (to the endoscope working channel), a pneumatic footswitch (alternate control to initiate air pulse, one piece is included as a standard set component), and an RS-232 connection so that unit displays may be available to other system peripheral devices (Addon Camera).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper Airway innervated by the Superior Laryngeal Nerve; the Left and Right Anterior Wall of the Pyriform Sinus and the Left and Right Aryepiglottic Folds.
Indicated Patient Age Range
Adult and Pediatric patient populations
Intended User / Care Setting
Not Found
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)
The submission for substantial equivalence was not based on an assessment of clinical performance data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K921707, K870750, K942210, K823701, K823700, K904625
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1200 Two-point discriminator.
(a)
Identification. A two-point discriminator is a device with points used for testing a patient's touch discrimination.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
MAY 1 1 2017
Mr. Paul Silva Regulatory Affairs Coordinator Pentax Precision Instrument Corporation 3117 Commerce Parkway Miramar, Florida 33025
Re: K964815
Trade/Device Name: AP-4000, Air Pulse Sensory Stimulator Regulation Number: 21 CFR 882.1200 Regulation Name: Two-point discriminator Regulatory Class: Class I Product Code: LLN Dated: August 12, 1997 Received: August 13, 1997
Dear Mr. Silva:
This letter corrects our substantially equivalent letter of September 4, 1997.
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. Iisting 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.
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 Parts 801 and 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements
1
Page 2 - Mr. Paul Silva
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 Parts 801 and 809), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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, Michae
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page _ 1 of _ 1 . .
510(k) Number (if Known):
AP-4000, Air Pulse Sensory Stimulator Device Name:
Indications for IJse: ....... . .... ..... ...... . . . . . . . . . . .
The AP-4000, Air Pulse Sensory Stimulator, is intended to elicit Laryngeal Closure Reflex (Swallow) and to measure the sensory discrimination threshold at which the reflex occurs in the area of the Upper Airway innervated by the Superior Laryngeal Nerve. The structures being stimulated in the area of the Upper Airway innervated by the Superior Laryngeal Nerve are: the Left and Right Anterior Wall of the Pyriform Sinus and the Left and Right Aryepiglottic Folds. The device is intended to be used with the Pentax FNL-10AP or FNL-10RAP, Fiber Naso -Pharyngo- Laryngo Scope, introduced per nasally in Adult and Pediatric patient populations with suspected Dysphagia.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thomas J. Callahan
(Division Sign-Off) Division of C:nthinvascular, Respiratory, and Neurological Devices 510(k) Number_1964815
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
3
KS053 DOCUMENT NUMBER: 03-19-97 DATE PREPARED:
PAGE 1 OF 1 PAUL SILVA PREPARED BY:
510(K) SUMMARY: AP-4000, AIR PULSE SENSORY STIMULATOR
SUBMITTER INFORMATION: Paul Silva
Pentax Precision Instrument Corporation 30 Ramland Road SEP - 4 1997 Orangeburg, NY, 10962 TEL: (914)-365-0700
NAME OF DEVICE:
Trade Name: AP-4000. Air Pulse Sensory Stimulator Classification Name: Endoscope and Accessories (78KOG) {876.1500}
PREDICATED DEVICE(S) INFORMATION:
| FNL-15P2, Fiber NasoPharyngo(Laryngo)scope | Pentax | K921707 |
|---|---|---|
| Reflex Hammer, Manual | *Class 1 device, no 510(k) clearance | |
| Keeler Non Contact Tonometer | Keeler Instruments | K870750 |
| Companion 335, Nasal CPAP System | Nellcor Puritan Bennett | K942210 |
| Motility Catheter | MAI | K823701 |
| Infusion Pump | MAI | K823700 |
| Synetics liberty System, PC Polygraph | Synetics | K904625 |
DEVICE DESCRIPTION:
The AP-4000, Air Pulse Sensory Stimulator, is an endoscopic accessory that must be used with the Pentax FNL-10AP or FNL-10RAP, Fiber Naso-Pharyngo-(Laryngo) Scopes. The AP-4000 is a software controlled device. The device contains an Air Pump and the mechanics to control the pressure of a 50 millisecond (ms) air pulse, delivered through the FNL-10AP working channel. The device is connected to the endoscope working channel with an Air Supply Tube (two pieces are included with the device as standard set components). The device front panel has controls and displays to allow a desired pressure for the 50 ms air pulse to be selected (in the range 2 mm Hg to 10 mm Hg), the air pulse to be initiated, and the actual pressure of the delivered air pulse to be displayed. There are connections for the Air Supply Tube (to the endoscope working channel), a pneumatic footswitch (alternate control to initiate air pulse, one piece is included as a standard set component), and an RS-232 connection so that unit displays may be available to other system peripheral devices (Addon Camera).
INTENDED USE:
The AP-4000, Air Pulse Sensory Stimulator, is intended to elicit Laryngeal Closure Reflex (Swallow) and to measure the sensory discrimination threshold at which the reflex occurs in the area of the Upper Airway innervated by the Superior Laryngeal Nerve. The structures being stimulated in the area of the Upper Airway innervated by the Superior Laryngeal Nerve are: the Left and Right Anterior Wall of the Pyriform Sinus and the Left and Right Aryepiglottic Folds. The device is intended to be used with the Pentax FNL-10AP or FNL-10RAP, Fiber Naso -Pharyngo- Laryngo Scope, introduced per nasally in Adult and Pediatric patient populations with suspected Dysphagia.
COMPARISON TO PREDICATED DEVICE(S):
The submission for substantial equivalence included AP-4000, Air Pulse Sensory Stimulator, specifications, literature, the identification of standard set components and optional accessories. Comparison tables were provided to illustrate the comparisons to the predicated devices. The submission for substantial equivalence was not based on an assessment of clinical performance data.