(95 days)
Not Found
No
The description focuses on the device's function of warming and storing items, with no mention of AI, ML, or related technologies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device warms blankets, linens, and solutions for patient comfort and preparation for medical procedures, but it does not directly treat or diagnose a disease or condition. Its function is auxiliary to therapeutic medical care.
No
The device is designed to warm blankets, linens, and solutions, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly describes a physical warming cabinet designed to store and warm items, indicating it is a hardware device, not software-only.
Based on the provided information, the Amsco Warming Cabinet is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to warm blankets, linens, and solutions for patient comfort and use in medical procedures. This is a physical process applied to materials, not a diagnostic test performed on biological samples.
- Device Description: The description focuses on storage capacity and warming capabilities for non-biological materials.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
- Predicate Devices: The listed predicate devices are also warming cabinets, which are not typically classified as IVDs.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Amsco Warming Cabinet does not perform this function.
N/A
Intended Use / Indications for Use
The Amsco Warming Cabinet is designed to raise the temperature of blankets, linens and sterile surgical irrigation solutions and IV solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications.
Product codes
LGZ
Device Description
The Amsco Warming Cabinet is designed to store and warm sterile IV solutions, surgical irrigation solutions, linens and/or blankets to an acceptable level for hospital and surgical outpatient center applications.
The upper compartment of the 18" (457mm) deep model holds up to 24(1-liter) liquid bags or bottles and 14 (1-liter) IV solution bags; the lower compartment holds up to 72 (1-liter) liquid bags or bottles.
The upper compartment of the 24" (610mm) deep model holds up to 30 (1-liter) surgical flasks; the lower compartment holds up to 90 (1-liter) surgical flasks.
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
hospital and surgical outpatient center applications.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the text "Public Health Service" in a bold, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall appearance is simple and straightforward, focusing on conveying the name of the organization.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Robert F. Sullivan Senior Director FDA Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060
JAN 1 0 2017
Re: K092823
Trade/Device Name: Amsco Warming Cabinet Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ Dated: September 11, 2009 Received: September 14, 2009
Dear Mr. Sullivan:
This letter corrects our substantially equivalent letter of December 18, 2009.
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.
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
1
Page 2 - Mr. Robert F. Sullivan
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 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 vours.
Erin I. Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):
Device Name:
Amsco Warming Cabinet
Indications For Use:
The Ansco Warming Cabinet is designed to raise the temperature of blankets, lineus and sterile surgical irrigation solutions and IV solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Austin for Gz
(Division Sign-Off) Division of Anesthesiology, General Hospital Intection Control, Dental Devices
510(k) Number: 692823
3
Image /page/3/Picture/0 description: The image shows a handwritten text that appears to be a word or a combination of letters and symbols. The characters are written in a cursive style, with some letters connected to each other. The writing is dark and bold, contrasting with the white background, making it easily readable.
STERIS.
DEC 1 8 2009
510(k) Summary For Amsco Warming Cabinet
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459
Contact:
Robert F. Sullivan Senior Director FDA Regulatory Affairs Telephone: 440-392-7695 Fax No: 440-357-9198
Summary Date:
September 11, 2009
STERIS Corporation • 5960 Heisley Road • Mentor. OH 44060-1834 USA • 440-354-2600
September 11, 2009
4
Device Name 1.
| Trade Name: | Amsco Warming Cabinet |
|---|---|
| Common/usual Name: | Warming Cabinet |
| Classification Name: | Warmer, Irrigation Solution |
2. Predicate Device
STERIS Amsco Warming Cabinet (Pre-Amendment) Enthermics EC-7701 Fluid Warming Cabinet, K993797, January 20, 2000
Warmer, Cabinet
3. Description of Device
The Amsco Warming Cabinet is designed to store and warm sterile IV solutions, surgical irrigation solutions, linens and/or blankets to an acceptable level for hospital and surgical outpatient center applications.
The upper compartment of the 18" (457mm) deep model holds up to 24(1-liter) liquid bags or bottles and 14 (1-liter) IV solution bags; the lower compartment holds up to 72 (1-liter) liquid bags or bottles.
The upper compartment of the 24" (610mm) deep model holds up to 30 (1-liter) surgical flasks; the lower compartment holds up to 90 (1-liter) surgical flasks.
4. Intended Use
The Amsco Warming Cabinet is designed to raise the temperature of blankets, linens and sterile surgical irrigation solutions and IV solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications.
ડ. Description of Safety and Substantial Equivalence
The Amsco Warming Cabinet is nearly identical to the two predicate devices in all material respects. A table comparing the technological characteristics of the proposed Amsco Warming Cabinet to the predicates is provided in Table 5-1.
5
STERIS TRADITIONAL 510(k) PREMARKET SUBMISSION STERIS Amsco Warming Cabinet
| Features | Technological Characteristics | ||
|---|---|---|---|
| Amsco Warming Cabinet | |||
| (IV Solution Capability) | Amsco Warming Cabinet | ||
| (Pre-amendment) | EC-7701 Fluid Warming | ||
| Cabinet (K993797) | |||
| Intended Use | The Amsco Warming Cabinet | ||
| is designed to raise the | |||
| temperature of blankets, linens | |||
| and sterile surgical irrigation | |||
| solutions and IV solutions to | |||
| an acceptable level for various | |||
| surgical, obstetrical, | |||
| emergency, critical care and | |||
| other healthcare applications. | |||
| The Amsco Warming Cabinet | |||
| is designed to hold a | |||
| combination of flasks and/or | |||
| dry goods. | Amsco Warming Cabinet is for | ||
| heating flasked solutions, | |||
| blankets and similar clinical | |||
| articles. | The Enthermics Medical | ||
| Systems EC-7701 Fluid | |||
| Warming Cabinet is | |||
| designed to safely store | |||
| and warm irrigation fluids | |||
| or injection fluids in | |||
| accordance with the | |||
| recommended warming | |||
| temperatures and storage | |||
| times stated in the fluid | |||
| manufacturer's labeling. | |||
| Heating | |||
| System | Electric heater and fan blower | ||
| (Convection heating) | Steam heat or Electric heater | ||
| blanket and fan blower | |||
| (Convection heating) | Fully insulated | ||
| electrothermal cable array | |||
| (Convection heating) | |||
| Unit | |||
| Configuration | Single/Double | Single/Dual | Single |
| Unit Depth | 18" or 24" | 18" or 24" | |
| Model | Wall or Counter | Wall or Counter | Wall |
| Interior and | |||
| Exterior | |||
| Surfaces | Stainless Steel, ABS Plastic | ||
| and laminated galvanized steel | Stainless Steel | Stainless Steel | |
| Installation | Free-Standing (mobile) or | ||
| Recessed | Open-Mounted or Recessed | Free-standing (mobile) or | |
| Recessed | |||
| Door | Stainless Steel (Solid and | ||
| Glass) | Stainless Steel | Stainless Steel (Glass) | |
| Cabinet | |||
| Storage | |||
| Capacity | 18" upper / single chamber - | ||
| 3.2 cu ft - up to 24 (1-liter) | |||
| bottles |
18" lower chamber - 8.5 cu ft
- up to 72 (1-liter) bottles
24" upper / single chamber -
4.3 cu ft - up to 30 (1-liter)
bottles
24" lower chamber - 11.6 cu ft
- up to 90 ( 1-liter) bottles | Dual Compartment Model -
Two shelves
15 flasks - 18" upper
45 flasks - 18" lower
20 flasks - 24" upper
60 flasks - 24" lower
Single Compartment Model -
One shelf
15 flasks - 18"
20 flasks - 24" | The cabinet is equipped
with three (3) white,
epoxy-coated wire baskets,
each with a 24 liter
capacity. |
| Features | | | |
| Cabinet
Volume | Amsco Warming Cabinet
(IV Solution Capability)
18" upper chamber - 3.1 cu ft
24" upper chamber - 4.2 cu ft
18" lower chamber - 8.9 cu ft
24" lower chamber - 12 cu ft | Amsco Warming Cabinet (Pre-amendment)
18" upper chamber - 3.1 cu ft
24" upper chamber - 4.2 cu ft
18" lower chamber - 8.9 cu ft
24" lower chamber - 12 cu ft | EC-7701 Fluid Warming
Cabinet (K993797) |
| Controls | Digital Push Button keypad /
power switch / Digital LCD
temperature display / mode
selection buttons / door ajar
indicator / Over-temperature
light for each compartment /
Data port for retrieval of
stored temperatures. | Thermostat / power switch /
fuse with indicating light / color
coded temperature selector | Electronic control consists
of 4 digit LED display,
on/off key, increase and
decrease keys, integrated
lock feature and a series of
prompt sequence
indicators. |
| Software | Unit contains software | Not Applicable | Not applicable |
| Temperature
Selection
Range | 90°F (32°C) to 160°F (71°C) | 95°F to 150°F (35°C to 65°C) | 90°F (32°C) to 150°F
(66°C) |
| Temperature
Lock | Temperature lock-out function
to prevent unauthorized
temperature changes. | Not Available | The device allows the user
to "lock" the mode (IRR or
INJ) and temperature
setting controls.
Available as an option |
| Door Lock | All configurations will be
equipped with either a manual
mechanical door lock or
optional electronic door lock
system for each compartment | Available by SSQ (Special
Sales Quote) only | Available as an option |
| Over
Temperature
Alarm Point | Visual and audible alarm if
unit has a chamber
temperature greater than 10°F
(5.5°C) above set temperature.
In the event of an over temp
condition, sensors
automatically turns off the
heater(s). | Visual alarm if unit has a
chamber temperature greater
than 12°F above set
temperature. In the event of an
over temp condition, sensors
automatically turns off the
heater(s). | Visual and audible alarm if
unit has a chamber
temperature greater than
10°F (5.5°C) above set
temperature. In the event
of an over temp condition,
the heating system shuts
down. |
| Voltage
Requirements | 110/120 Vac, 220/240 Vac
nominal, 50/60 HZ | Electric Model: 110/120 Vac,
220/240 Vac nominal, 50/60
HZ
Steam Model: 120 VAC single
phase | 125 Vac, 60 HZ, 1 ph |
Table 5-1 Summary of the Proposed Device and Predicate Devices Technological Characteristics
6
STERIS TRADITIONAL 610(k) PREMARKET SUBMISSION
STERIS Amsco Warming Cabinet
.