(311 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description is for a physical chamber.
Yes
The device is used to treat various medical conditions such as venous stasis ulcers, decubitus stasis ulcers, diabetic ulcers, frostbite, and post surgical wounds, which aligns with the definition of a therapeutic device.
No
The "Intended Use / Indications for Use" section lists various conditions and wounds (e.g., "VENOUS STASIS S", "DECUBITUS STASIS UL CERS", "DIABETIC ULCERS", "FROSTBITE", "POST SURGICAL WOUNDS") that the device is intended to address. The device itself is described as a "Hyper Pulse Intermittent Topical Oxygen Chamber". This description suggests that the device is used for treatment or therapy related to these conditions, rather than for diagnosing them. There is no mention of the device performing any type of analysis, measurement, or detection to identify or characterize a disease or condition.
No
The device description explicitly states "Hyper Pulse Intermittent Topical Oxygen Chamber, Models C-100; CB-100", which clearly indicates a hardware device (a chamber) and not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (treating venous stasis, decubitus ulcers, diabetic ulcers, frostbite, and post-surgical wounds) are all related to treating conditions in a living patient. IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: The description "Hyper Pulse Intermittent Topical Oxygen Chamber" suggests a device that applies oxygen externally to a wound, which is a therapeutic treatment, not a diagnostic test.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on laboratory tests.
- Using reagents or assays.
Therefore, the Hyper Pulse Intermittent Topical Oxygen Chamber, Models C-100; CB-100, as described, is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- VENOUS STASIS S
- DECUBITUS STASIS UL CERS
- DIABETIC ULCERS
- вики с
- FROSTBITE
-POST SURGICAL WOUNDS
Product codes
KPJ
Device Description
Hyper Pulse Intermittent Topical Oxygen Chamber, Models C-100; CB-100
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
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.
Not Found
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
§ 878.5650 Topical oxygen chamber for extremities.
(a)
Identification. A topical oxygen chamber for extremities is a device that is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers such as bedsores.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Topical Oxygen Chamber for Extremities.” See § 878.1(e) for the availability of this guidance document.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other, and stylized to look like an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Beverly Bennett President Stephenson Industries ... .................................................................................................................................................... 1648 Beaver Dam Road Point Pleasant, New Jersey 08742
JUL 2 8 1997
Re: K963777
Trade Name: Hyper Pulse Intermittent Topical Oxygen Chamber, Models C-100; CB-100 Regulatory Class: III Product Code: KPJ Dated: February 12, 1997 Received: February 18, 1997
Dear Ms. Bennett:
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
1
Page 2 - Ms. Beverly Bennett
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) 594-4595. 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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page _ of _
510(k) Number (if known): K963777
Device Name: Hyper Pulse Intermittent Topical Oxygen
Chamber, Models C-100; CB-100
Indications For Use:
-
VENOUS STASIS S
-
DECUBITUS STASIS UL CERS - DIABETIC ULCERS - вики с - FROSTBITE -POST SURGICAL WOUNDS
(PLEASED DO MOT WILLTI DELOW TIDE LINE - CONTINUE ON ANOTHER FAUE IF NEEUEU)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Generel Restorative Devices
510(k) Number K963777
Presenption Usc (Pct 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)