(143 days)
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Not Found
No
The provided text describes a surgical wand for tissue resection and ablation. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses solely on the device's intended use and anatomical sites.
Yes
The device is indicated for medical procedures such as resection and ablation of soft tissue, and hemostasis of blood vessels, which are therapeutic interventions.
No.
The device is indicated for surgical procedures involving resection, ablation, and hemostasis of soft tissue, which are therapeutic actions, not diagnostic ones.
No
The intended use describes a "Wand with Integrated Finger Switches" for surgical procedures, which clearly indicates a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for surgical procedures (resection, ablation, hemostasis) directly on soft tissue and blood vessels within the body during arthroscopic and orthopedic procedures.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
This device is clearly an in vivo device, meaning it is used within the living body, not on samples outside the body.
N/A
Intended Use / Indications for Use
The Ambient HipVac 50 Wand with Integrated Finger Switches is indicated for resection and ablation of soft tissue, and hemostasis of blood vessels less than 1 mm (via coagulation) in the following arthroscopic and orthopedic procedures:
Joint: All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow)
Ablation/Debridement: Articular Cartilage, Bursectomy, Chondroplasty, Fascia, Ligament, Scar Tissue, Soft Tissue, Synovectomy, Tendon
Excision/Resection: Articular Labrum, Capsule, Cysts, Ligament, Loose Bodies, Plica Removal, Scar Tissue, Soft Tissue, Synovial Membrane, Tendon
Joint: Hip
Excision/Resection: Acetabular Labrum
Joint: Knee
Ablation/Debridement: ACL/PCL, Notchplasty
Excision/Resection: Capsular Release, Cartilage Flaps, Discoid Meniscus, Lateral Release, Meniscal Cystectomy, Meniscectomy, Villusectomy
Joint: Shoulder
Ablation/Debridement: Acromioplasty, Subacromial Decompression
Excision/Reasection: Frozen Shoulder Release, Glenoid Labrum
Joint: Wrist
Excision/Reasection: Triangular Fibrocartilage
Product codes
GEI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow)
Hip
Knee
Shoulder
Wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 21, 2016
ArthroCare Corporation Ms. Ashley M. Johnston, Regulatory Affairs Specialist 7000 West William Cannon Drive, Building One Austin, Texas 78735
Re: K161481
Trade/Device Name: Ambient HipVac 50 Wand with Integrated Finger Switches Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 19, 2016 Received: September 20, 2016
Dear Ms. Johnston:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21 CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161481
Device Name
Ambient HipVac 50 Wand with Integrated Finger Switches
Indications for Use (Describe) Please see attached.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K161481
The Ambient HipVac 50 Wand with Integrated Finger Switches is indicated for resection and ablation of soft tissue, and hemostasis of blood vessels less than 1 mm (via coagulation) in the following arthroscopic and orthopedic procedures:
| Joint | Ablation/Debridement | Excision/Resection |
|---|---|---|
| All Joints (Hip, Knee, | ||
| Shoulder, Wrist, Ankle, | ||
| Elbow) | ■ Articular Cartilage | ■ Articular Labrum |
| ■ Bursectomy | ■ Capsule | |
| ■ Chondroplasty | ■ Cysts | |
| ■ Fascia | ■ Ligament | |
| ■ Ligament | ■ Loose Bodies | |
| ■ Scar Tissue | ■ Plica Removal | |
| ■ Soft Tissue | ■ Scar Tissue | |
| ■ Synovectomy | ■ Soft Tissue | |
| ■ Tendon | ■ Synovial Membrane | |
| ■ Tendon | ||
| Hip | ■ Acetabular Labrum | |
| Knee | ■ ACL/PCL | ■ Capsular Release |
| ■ Notchplasty | ■ Cartilage Flaps | |
| ■ Discoid Meniscus | ||
| ■ Lateral Release | ||
| ■ Meniscal Cystectomy | ||
| ■ Meniscectomy | ||
| ■ Villusectomy | ||
| Shoulder | ■ Acromioplasty | ■ Frozen Shoulder Release |
| ■ Subacromial Decompression | ■ Glenoid Labrum | |
| Wrist | ■ Triangular Fibrocartilage |
4
Indications for Use
510(k) Number (if known) K161481
Device Name
Ambient HipVac 50 Wand with Integrated Finger Switches
Indications for Use (Describe) Please see attached.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
The Ambient HipVac 50 Wand with Integrated Finger Switches is indicated for resection and ablation of soft tissue, and hemostasis of blood vessels less than 1 mm (via coagulation) in the following arthroscopic and orthopedic procedures:
| Joint | Ablation/Debridement | Excision/Resection |
|---|---|---|
| All Joints (Hip, Knee, | ||
| Shoulder, Wrist, Ankle, | ||
| Elbow) | ■ Articular Cartilage | ■ Articular Labrum |
| ■ Bursectomy | ■ Capsule | |
| ■ Chondroplasty | ■ Cysts | |
| ■ Fascia | ■ Ligament | |
| ■ Ligament | ■ Loose Bodies | |
| ■ Scar Tissue | ■ Plica Removal | |
| ■ Soft Tissue | ■ Scar Tissue | |
| ■ Synovectomy | ■ Soft Tissue | |
| ■ Tendon | ■ Synovial Membrane | |
| ■ Tendon | ||
| Hip | ■ Acetabular Labrum | |
| Knee | ■ ACL/PCL | ■ Capsular Release |
| ■ Notchplasty | ■ Cartilage Flaps | |
| ■ Discoid Meniscus | ||
| ■ Lateral Release | ||
| ■ Meniscal Cystectomy | ||
| ■ Meniscectomy | ||
| ■ Villusectomy | ||
| Shoulder | ■ Acromioplasty | ■ Frozen Shoulder Release |
| ■ Subacromial Decompression | ■ Glenoid Labrum | |
| Wrist | ■ Triangular Fibrocartilage |