(89 days)
Not Found
No
The device description details a physical restraint system made of straps, buckles, and foam. There is no mention of any software, data processing, or algorithmic components that would suggest the use of AI or ML.
No
The device is used to limit patient movement for safety and facilitate treatment, rather than directly providing therapy.
No
The device, Kenad Limb Holders, is used to limit patient movement for treatment, examination, or protection, not to diagnose a condition.
No
The device description clearly outlines physical components made of materials like polyurethane foam, Velcro, metal buckles, and woven polypropylene, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Kenad Limb Holders are physical restraints used to limit patient movement. The intended use is for "medical purposes where a patient's arm and leg movement must be limited... for treatment, examination or protection." This is a physical intervention, not a diagnostic test performed on a sample.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
The device is a physical medical device used for patient restraint.
N/A
Intended Use / Indications for Use
Kenad Limb Holders are indicated for medical purposes where a patient's arm and leg movement must be limited to the extent necessary for treatment, examination or protection of the patient or others.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Kenad Limb Holders subject to this Premarket Notification are depicted in the figure at ATTACHMENT 6. As depicted in this figure. Kenad Limb Holders are assemblies of the following modules: Ankle/Wrist Cuff, Ankle/Wrist Strap, Connector Strap, Quick Release Buckle and Bed Strap.
The Ankle/Wrist Cuff is a rectangular, two sided material. On the side which contacts skin, the cuff is made from blue or white polyurethane foam. At one end of the rectangle, a patch of Velcro hooks are stitched to the foam with 12 pound nylon thread. Heat bonded to the foam back is a piece of blue or white Velcro pile.
Except for Black Limb Holder with Removable Cuff (Catalog # 50-1600), the Ankle/Wrist Strap is affixed to the Ankle/Wrist Cuff by sewing using 12 pound nylon thread. For Black Limb Holder, a Velcro hook strip is sewn to one end of the Ankle/Wrist Strap. The Velcro hook strip then affixes to the Velcro pile of the cuff. Affixed by sewing to one end of the Ankle/Wrist Strap is a polished metal buckle for locking the Ankle/Wrist strap in place around the ankle/wrist.
The Connector Strap is affixed by sewing with 12 pound nylon thread to the Ankle/Wrist Strap. Affixed by sewing to the other end of the Connector Strap is the female or male end of the Quick Release Buckle.
The Bed Strap comes as either a loop able or threadable end for anchoring to a fixed object. Affixed by sewing to one end of the Connector Strap is the complementary female or male end of the Quick Release Buckle.
The material used to make the straps is woven polypropylene. The polypropylene color is either black or white, and its width is either a nominal 1 or 1.5 inch. The variations are outlined in more detail in the Table also included at ATTACHMENT 6.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's arm and leg
Indicated Patient Age Range
adults and children.
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)
More than 150,000 pairs of Kenad Limb Holders were sold over the last 5 years. Assuming 100% usage, there have been more than 300,000 contacts between ankles and/or wrists over the last 5 years. During this time, Kenad received no patient injury or product failure complaints.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The absence of patient injury or product failure complaints following more than 300,000 product uses over 5 years indicates these products are safe and effective.
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.
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
§ 880.6760 Protective restraint.
(a)
Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.(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 the limitations in § 880.9.
0
510(k) SUMMARY
PERSONNEL AND DATE (807.92(a)(1)) 1.
1.1. Submitter
Kenad SG Medical Inc. 2692 Huntley Memphis, TN 38132
1.2.. Contact Person
Kenneth Elmore President and CEO Kenad SG Medical Inc.
1.3.. Date Of summary Preparation
This summary was prepared in April and May 1996.
2. DEVICE NAME (807.92(a)(2))
- As noted in the Cover Letter, five similar devices are grouped within .. .. this 510(k) notification. These devices differ only in minor design aspects. Their function, application and use is identical.
2.1. Trade Or Proprietary Name
Patient Protective Limb Holder (Universal) is the trade or proprietary name for the devices which are the subject of this Premarket Notification Submission. Within this name, there are five Kenad Limb Holders.
| KENAD Catalog # | Description |
|---|---|
| 50-1400 | White Limb Holder |
| 50-1500 | Deluxe Blue Limb Holder |
| 50-1500e | Economy White Limb Holder |
| 50-1600 | Black Limb Holder w/ |
| Removable Cuff | |
| 50-1700 | Pediatric Limb Holder |
1
2.2. Common Or Usual Name
Protective Restraint 21CFR 880.6760
3. LEGALLY MARKETED DEVICE (807.92(a)(3))
The Kenad Limb Holders that are the subject of this Premarket Notification Submission are comparable to Patient Protective Limb Holder from Danek Medical. Inc. Danek successfully filed a premarket notification for Patient Protective Limb Holder at Document Control number K823815, January 17, 1983.
4. DEVICE DESCRIPTION (807.92(a)(4)) (p 11)
4.1. General Description
The Kenad Limb Holders subject to this Premarket Notification are depicted in the figure at ATTACHMENT 6. As depicted in this figure. Kenad Limb Holders are assemblies of the following modules: Ankle/Wrist Cuff, Ankle/Wrist Strap, Connector Strap, Quick Release Buckle and Bed Strap.
The Ankle/Wrist Cuff is a rectangular, two sided material. On the side which contacts skin, the cuff is made from blue or white polyurethane foam. At one end of the rectangle, a patch of Velcro hooks are stitched to the foam with 12 pound nylon thread. Heat bonded to the foam back is a piece of blue or white Velcro pile.
Except for Black Limb Holder with Removable Cuff (Catalog # 50-1600), the Ankle/Wrist Strap is affixed to the Ankle/Wrist Cuff by sewing using 12 pound nylon thread. For Black Limb Holder, a Velcro hook strip is sewn to one end of the Ankle/Wrist Strap. The Velcro hook strip then affixes to the Velcro pile of the cuff. Affixed by sewing to one end of the Ankle/Wrist Strap is a polished metal buckle for locking the Ankle/Wrist strap in place around the ankle/wrist.
The Connector Strap is affixed by sewing with 12 pound nylon thread to the Ankle/Wrist Strap. Affixed by sewing to the other end of the Connector Strap is the female or male end of the Quick Release Buckle.
2
The Bed Strap comes as either a loop able or threadable end for anchoring to a fixed object. Affixed by sewing to one end of the Connector Strap is the complementary female or male end of the Quick Release Buckle.
The material used to make the straps is woven polypropylene. The polypropylene color is either black or white, and its width is either a nominal 1 or 1.5 inch. The variations are outlined in more detail in the Table also included at ATTACHMENT 6.
4.2. How Limb Holders Function
The Ankle/Wrist Cuff is placed around the ankle/wrist, and held in place by Velcro. The cuff is then surrounded by the Ankle/Wrist Strap, and held in place by a buckle. The Bed Strap is affixed to an immovable object either by looping or threading, and the Bed Strap is connected to the Connector Strap via the Quick Release Buckle. Slack is removed from the Connector Strap so that the limb is comfortably held close to the bed.
INTENDED USE (807.92(a)(5)) 5.
5.1. ... Indications
Kenad Limb Holders are indicated for medical purposes where a patient's arm and leg movement must be limited to the extent necessary for treatment, examination or protection of the patient or others.
5.2. Patient Population
Kenad Limb Holders are used with adults and children.
5.3. Indications Different From Substantially Equivalent Device
The indications and patient population for the Kenad devices are identical to the legally marketed device cited above at Section 10.
3
6. COMPARISON TO LEGALLY MARKETED DEVICE (807.92(a)(6))
The Kenad Limb Holders that are the subject of this Premarket Notification Submission are comparable to Patient Protective Limb Holder from Danek Medical, Inc. A comparison of these devices was provided at Section 6 in the Premarket Notification Submission.
7. PERFORMANCE DATA (807.92(b))
More than 150,000 pairs of Kenad Limb Holders were sold over the last 5 years. Assuming 100% usage, there have been more than 300,000 contacts between ankles and/or wrists over the last 5 years. During this time, Kenad received no patient injury or product failure complaints.
8. SAFETY, EFFICACY AND PERFORMANCE CONCLUSION (807.92(b)(3))
The absence of patient injury or product failure complaints following more than 300,000 product uses over 5 years indicates these products are safe and effective.
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ATTACHMENT 6
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Image /page/5/Picture/0 description: The image shows a diagram of a restraint system. The system includes an ankle/wrist cuff and strap, a connector strap, and a quick-release buckle. The system also includes a bed strap that is loopable and a bed strap that is threadable.
ﯿﻨﭧ- ﭘﺎﮐﺴﺘﺎﻥ ﮐﮯ ﻟﯿﻨﮉ ﮐﮯ ﺍﻧﺘﻈﺎﻣﯿﺎﺕ ﮐﮯ ﺷﮩﺮ
i
6
| CATALOG # | 50-1400
White
Limb Holder | 50-1500e
Economy
Limb Holder | 50-1500
Deluxe
Limb Holder | 50-1700
Pediatirc
Limb Holder | 50-1600
Detachable
Cuff
Limb Holder |
|----------------------------------------|---------------------------------|------------------------------------|----------------------------------|-------------------------------------|----------------------------------------------|
| CUFF | | | | | |
| Color | White | White | Blue | Blue | Blue |
| Dimensions (Nominal) | 12 X 3 | 12 X 3 | 13 X 3 | 9 X 2 | 13 X 3 |
| STRAP (Ankle/Wrist, Bed,
Connector) | | | | | |
| Color | White | White | White | White | White |
| Width | 1.5" | 1" | 1.5" | 1" | 1.5" |
| BED STRAP | | | | | |
| Attachment | Threadable | Loopable | Loopable | Loopable | Loopable |
| QUICK RELEASE | | | | | |
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