(70 days)
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 also not provided, but the intended use and predicate devices suggest a mechanical cutting system.
No
A therapeutic device is one that treats a disease or condition. This device is for cutting and dissection of soft tissue, which is a surgical tool, not a therapeutic treatment.
No
The device's intended use is "cutting and dissection of soft tissue," which is a therapeutic rather than a diagnostic function.
No
The device is described as a "Hydro-Jet" intended for "cutting and dissection of soft tissue," which strongly implies a physical device that uses water jets for surgical procedures. This is not consistent with a software-only medical device.
Based on the provided information, the Helix Hydro-Jet is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cutting and dissection of soft tissue such as liver and kidney in open abdominal surgery." This describes a surgical tool used directly on the patient's body during a procedure.
- 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. The Helix Hydro-Jet does not perform such tests.
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples, reagents, or diagnostic results, which are hallmarks of IVD devices.
Therefore, the Helix Hydro-Jet is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Helix Hydro Jet is intended for cutting and dissection of soft tissue such as liver and kidney in open abdominal surgery.
Product codes
FQH
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue such as liver and kidney
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
The company did not conduct, nor depend on, clinical studies in order to establish substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K982266, K991383, K993564, K990430
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5475 Jet lavage.
(a)
Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.(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
OCT 1 0 2001 510(k) Summary
Introduction
This 510(k) Summary document is intended to comply with requirements of the SMDA and 21CFR 807.92. FDA may make this summary available to the public within 30 days following a finding of substantial equivalence.
510(k) Submitted by
Andreas Pein Medizintechnik, GmbH Wilhelm-Hennemann-Straße 09 19061 Schwerin, Germany Tel: +49 385 395 70 0 / Fax: +49 385 395 70 10
USA Submission Correspondent
Robert N. Clark Medical Device Regulatory Advisors Golden, Colorado, USA Tel: 303-234-9412 / Fax: 303-234-9413
Date Prepared
October 4, 2001
Trade Name of Device
Helix Hydro-Jet ®
Common Name of Device
Water Jet Dissector
510(k) Classification
Class II
Indications for Use
The Helix Hydro Jet is intended for cutting and dissection of soft tissue such as liver and kidney in open abdominal surgery.
1
Comparison to Predicate Devices
The following prior legally marketed devices have been used to establish substantial equivalence:
| K982266 | HydroCision Arthroscopic Cutting System | HydroCision, Inc. |
|---|---|---|
| K991383 | HydroCision Inc. Debridement System | HydroCision, Inc. |
| K993564 | Possis AngioJet Xpeedior Catheter | Possis Medical, Inc. |
| K990430 | Ultracision Harmonic Scalpel Hand Piece | Ethicon Endo-Surgery, Inc. |
Non-Clinical Testing
The requirements of the following standards have been used in part to establish substantial equivalence:
Biocompatibility Testing:
Biocompatibility testing was successfully completed for patient contact materials, according to the requirements of standard ISO 10993-1.
Safety Testing:
Safety testing was successfully completed on the device according to the requirements of standard EN 60601-1 / IEC 601-1.
EMC Testing:
EMC testing was successfully completed on the device according to the requirements of standard EN 60601-1-2.
The company did not conduct, nor depend on, clinical studies in order to establish substantial equivalence.
Risk Management
The device has been designed to either completely eliminate or mitigate all known health hazards associated with the use of the device. Health hazard risk reduction has been accomplished by rigorous application of a risk management program.
The user must be qualified in surgical procedures, trained in the use of water jet surgical cutting systems, and must be familiar with all labeling and instructions for use associated with the device.
Andreas Pein Medizintechnik believes that the Helix Hydro-Jet® is safe and effective when used as instructed by knowledgeable and trained personnel, and performs as well as or better than the legally marketed predicate devices for the purposes intended.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 0 2001
Andreas Pein Medizintechnik GMBH c/o Mr. Robert N. Clark Medical Device Regulatory Advisors 13605 West 7th Avenue Golden, Colorado 80401
Re: K012464
Trade/Device Name: Helix Hydro-Jet Regulation Number: 21 CFR 880.5475 Regulation Name: Jet Lavage Regulatory Class: Class II Product Code: FQH Dated: July 30, 2001 Received: August 1, 2001
Dear Mr. Clark:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.
3
Page 2 - Mr. Robert N. Clark
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow Jours ough finding of substantial equivalence of your device to a legally prematics notification: "The size 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 11 you desire openite arr. 009.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF Far 0671. Additionally, for questions on the promotion and advertising of Compinatee at (301) 59 - 165 - Office of Compliance at (301) 594-4639. Also, please note the your do roo, piedbe oomable of heference to premarket notification" (21CFR Part 807.97). regulation entitled, "Thisofaneing responsibilities under the Act may be obtained from the Outler general mionmation on your and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Wolm
Celia M. Witten, Ph.D., M.D. లు Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
| 510(k) Number: | K012464 |
|---|---|
| Device Name: | Helix Hydro-Jet |
Indications for Use:
The Helix Hydro-Jet is intended for cutting and dissection of soft tissue such as liver and kidney in open abdominal surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
SR
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K012464
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________