(48 days)
No
The description mentions a "computer controlled Air Control unit" but provides no details suggesting AI/ML functionality, and there are no mentions of AI, DNN, or ML, nor any information about training or test sets.
Yes
The device description states that the system "promote pressure reduction by redistributing patient weight," which indicates a therapeutic purpose of preventing or treating pressure ulcers.
No
Explanation: The device description clearly states its purpose is "low air loss support systems" that "promote pressure reduction by redistributing patient weight over a surface area / medium or by shifting patient weight". This describes a therapeutic device, not a diagnostic one.
No
The device description explicitly states it consists of two operating components: an electromechanical, computer-controlled Air Control unit (ACU) and an Air Floatation Mattress, indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro testing: The description focuses on a support system for patients, specifically a low air loss mattress system. There is no indication of the device being used to examine specimens from the human body in vitro.
- Focus on physical support: The device description clearly outlines components related to patient support and pressure redistribution, which are physical functions, not diagnostic ones.
- Lack of IVD-related keywords: The text does not contain any terms typically associated with IVD devices, such as "assay," "reagent," "sample," "diagnostic," "test," etc.
Therefore, based on the provided text, the AkroTech 4000T Kinetic Turning Low Air Loss (LAL) System is a medical device for patient support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes
8910Q
Device Description
The device, brand name AkroTech 4000T Kinetic Turning Low Air Loss (LAL) System, is substantially equivalent to the AkroTech 4000 Dynamic Low Air Loss (LAL) (K923077) (K923977).
- Both Low Air Loss support systems consist of two operating components: 1. The electromechanical, computer controlled Air Control unit (ACU) 2. The Air Floatation Mattress.
Both Systems promote pressure reduction by redistributing patient weight over a surface area / medium or by shifting patient we in a area / medium or by shifting patient weight of redistributing patient weight over a AkroTech 4000, the AirPad C AkroTech 4000, the AirBed Corporation (1240 S. Claudina St., Anaheim, CA 92805) is responsible for manufacturing the Akro Tech 4000T ACU and Lumex (CA 92805) Bay Shore, NY 11706, 2200 in was 11 Bay Shore, NY 11706-2290) is responsible for manufacturing the 4000T air flotation mattress and marketing the product. AirBed is registered with the FDA (#2029170) as is Lumex (#2427360). AirBed Corporation operates under operator #90A (#202 15.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5550 Alternating pressure air flotation mattress.
(a)
Identification. An alternating pressure air flotation mattress is a device intended for medical purposes that consists of a mattress with multiple air cells that can be filled and emptied in an alternating pattern by an associated control unit to provide regular, frequent, and automatic changes in the distribution of body pressure. The device is used to prevent and treat decubitus ulcers (bed sores).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
0
JUL 1 8 1996
510(k) Summary
AkroTech 4000T Kinetic Turning Low Air Loss (LAL) System
Lumex
1
Image /page/1/Picture/0 description: The image shows the logo for Lumex, which is written in large, bold, black letters. There is a thick black line underneath the company name. Below the line, it says "A Fuqua Enterprises Company" in a smaller font. The logo is simple and professional.
ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
510(k) Summary
| Submitter: | Lumex Medical Products, Inc.
100 Spence St.
Bay Shore, NY 11706
Phone (516)-273-2200
Fax (516)-273-2408 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joseph Zanetti
Divisional Quality Assurance Manager |
| Date Summary Prepared: | 5-22-96 |
| Classification Name: | Low air loss mattress flotation therapy - 8910Q
(890.5170) |
| Common / Usual Name:
: | Portable powered low air loss flotation therapy
mattress |
| Trade / Proprietary Name: | AkroTech 4000T Kinetic Turning Low Air Loss System |
| Establishment Registration: | 2427360 (Lumex Div. of Lumex, Inc.)
1318909 (Site of manufacture) |
| Classification: | Class II |
| Performance Standards: | None established under section 514 |
| Labeling / Promotional Materials: | See attachments |
| Substantial Equivalence: | This product is similar to the AkroTech 4000
product submitted by Lumex Div. of Lumex, Inc.
approved by the FDA reference number K923977. |
◀
2
510(k) Summary (cont'd)
The device, brand name AkroTech 4000T Kinetic Turning Low Air Loss (LAL) System, is substantially equivalent to the AkroTech 4000 Dynamic Low Air Loss (LAL)
(K923077) (K923977).
- Both Low Air Loss support systems consist of two operating components: 1. The electromechanical, computer controlled Air Control unit (ACU)
- The Air Floatation Mattress.
Section and the first of the first of the first of the first of the first of the first of the first of the first of the first of the first the first of the first of the first
Both Systems promote pressure reduction by redistributing patient weight over a surface
area / medium or by shifting patient we in a area / medium or by shifting patient weight of redistributing patient weight over a
AkroTech 4000, the AirPad C AkroTech 4000, the AirBed Corporation (1240 S. Claudina St., Anaheim, CA 92805) is responsible for manufacturing the Akro Tech 4000T ACU and Lumex (CA 92805)
Bay Shore, NY 11706, 2200 in was 11 Bay Shore, NY 11706-2290) is responsible for manufacturing the 4000T air flotation mattress and marketing the product. AirBed is registered with the FDA (#2029170) as is Lumex (#2427360). AirBed Corporation operates under operator #90A (#202
15.
COMPARISON OF OVERALL FEATURES OF AKROTECH 4000 DYNAMIC SYSTEM TO AKROTECH 4000T TURNING SYSTEM
| FEATURE | AKROTECH 4000
DYNAMIC | AKROTECH 4000T
TURNING |
|--------------------|---------------------------------------------------|-------------------------------------------------------------|
| Switch | On / Off Toggle | On / Off Toggle |
| Modality | Firm, Float, CPR,
Key Pad Lock, Alarm | Firm, Float, CPR,
Key Pad Lock, Alarm |
| Data Input Control | Up / Down | Up / Down |
| Input Information | Patient Weight | Patient Weight, Height,
Rotation Angle,
Time In Angle |
| Data Feedback | Patient Time In Use,
Cumulative Operating Time | Patient Time In Use,
Cumulative Operating Time |
| Air Control Zones | Six | Six |
| Air Flow Lines | One | One |
3
: ﺍﻟﻤﺮﺍﺟ ﺔ ﺑﺎﻟﻤﺎﺀ ﺑﺎﻟﻤﺎﺀ : "
COMPARISON OF ACU FEATURES OF AKROTECH 4000 DYNAMIC SYSTEM ACU TO AKROTECH 4000T TURNING SYSTEM ACU
| ACU FEATURE | AKROTECH 4000
DYNAMIC | AKROTECH 4000T
TURNING |
|--------------------------------|--------------------------|---------------------------|
| Computer | Same | Same |
| Hardware | Same | Same |
| Blower | Same | Same |
| Valves | Same | Same |
| Materials | Same | Same |
| Overall Dimensions | Same | Same |
| LCD Display | Same | Same |
| Key Pad | Same | Same |
| Labeling | See Attachment | See Attachment |
| Operator's Manual | See Attachment | See Attachment |
| Safety | UL544 and CSA Listed | UL544 and CSA Listed |
| Hose Connections | Locking Collet | Quick Disconnect |
| Graphic Overlay | Dynamic | Rotational |
| Computer Program /
Software | Dynamic | Rotational |
COMPARISON OF MATTRESS FEATURES OF AKROTECH 4000 DYNAMIC SYSTEM MATTRESS TO AKROTECH 4000T TURNING SYSTEM MATTRESS
| MATTRESS FEATURE | AKROTECH 4000
DYNAMIC | AKROTECH 4000T
TURNING |
|----------------------------|-------------------------------------------|-------------------------------------------|
| Air Control Zones | Same | Same |
| Air Flow Lines | Same | Same |
| Base | Same | Same |
| Bottom Cover | Same | Same |
| Top Cover | Same | Same |
| Tie Down Straps | Same | Same |
| Mattress Size | Same | Same |
| Safety | California # 117, UL544
and CSA Listed | California # 117, UL544
and CSA Listed |
| Intermediate Comfort Cover | Zipper Closure | Button Closure |
| CPR Deflate | Manual Release at Head End
Only | Manual Release at Both
Ends |
| Air Lines | Colored Extruded Air Hoses | Clear Air Hose with
Colored Spirals |
| Air Cells | 18 | 14 |
.