(49 days)
Not Found
No
The document describes a simple tube set for delivering irrigation fluid during arthroscopic procedures. There is no mention of any computational processing, image analysis, or learning algorithms. The performance studies focus on physical properties and functional equivalence, not algorithmic performance.
No
The device is a tube set that delivers irrigation fluid during arthroscopic procedures, acting as an accessory to a pump system. It does not directly treat or diagnose a disease or condition.
No
The device is described as a tube set for delivering irrigation fluid during arthroscopic procedures. Its intended use and description do not mention any diagnostic functions, but rather state its role in fluid management. The performance studies focus on functional equivalence and physical properties like leak testing and bond strength, not diagnostic accuracy.
No
The device description and performance studies clearly indicate that the device is a physical tube set, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to deliver irrigation fluid during arthroscopic procedures. This is a surgical procedure performed directly on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description reinforces that it's a tube set for delivering fluid during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for fluid management during a surgical procedure.
N/A
Intended Use / Indications for Use
The device intended to be used in conjunction with the FMS/Depuy/Mitek arthroscopic pump systems and delivers irrigation fluid both to and from the pump and to and from the operative site during arthroscopic procedures.
Product codes
HRX
Device Description
HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) are tube sets that deliver irrigation fluid both to and from the pump and to and from the operative site during arthroscopic procedures.
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
Performance testing was performed to demonstrate equivalence to the tube sets not the hardware referenced in the predicate devices. Hemodia's testing included bench testing for functional equivalence, tube set leak testing under pressure, bond strength. These test support that the design, packaging, sterilization & labeling of the TUBE SETS are substantially equivalent to currently marketed single use predicate devices. A clinical evaluation report was undertaken, supporting that clinical testing was not necessary to support substantial equivalence to predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K925160, K954465, K951843, K002040
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
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Image /page/0/Picture/2 description: The image shows a stylized letter H. The letter is drawn with thick, black lines and has a rounded, almost cartoonish appearance. The bottom of the letter has some text, but it is too blurry to read.
5. 510(K) SUMMARY
HEMODIA ARTHROSCOPY PUMP TUBE SETS - 510(k) Summary
| OWNER: | Hemodia S.A.S.
85 du Chêne Vert, 31670 Labège FRANCE
Tel: +33 5 61 00 71 81 - Fax: +33 5 61 00 47 40
remi.teuliere@hemoda.com |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Rene van de Zande, President & CEO
Emergo Group, Inc.
Phone: 512.327.9997 Fax: 512.327.9998
usagent@emergogroup.com |
| Date Summary Prepared: | October 15th 2013 |
| Device Trade Name: | HEMODIA ARTHROSCOPY PUMP TUBE SETS |
| Common Name: | Arthroscopic pump tube sets |
| Classification Name: | Arthroscope |
| Classification Code: | 21 CFR Part 888.1100
87 Orthopedic
Product Code: HRX |
| Equivalent Device(s): | OrthoConcept (FMS 4+ & disposables) K925160 FMS K954465 (FMS DUO ® + & disposables) FMS K951843 (REF. 4102CV INTERMEDIARY
TUBING, REF. 4509CV STERILE ZONE KIT) FMS K002040 (FMS SOLO® & disposables) |
| Device Description: | HEMODIA ARTHROSCOPY PUMP TUBE SETS
(HATS) are tube sets that deliver irrigation fluid both to
and from the pump and to and from the operative site
during arthroscopic procedures. |
| Intended and Indications
for Use: | The device intended to be used in conjunction with the
FMS/Depuy/Mitek arthroscopic pump systems and
delivers both irrigation fluid to and from the pump and to
and from the operative site during arthroscopic
procedures. |
| Technological
Characteristics | The TUBE SETS are similar in material (including
packaging material), design, function, and application to
the single use predicate devices. The device is not self-
powered but uses the same energy source (pumps) as
the predicate devices. The technological characteristics
are the same as the predicate device. |
| Performance Data: | Performance testing was performed to demonstrate
equivalence to the tube sets not the hardware
referenced in the predicate devices. Hemodia's testing
included bench testing for functional equivalence, tube
set leak testing under pressure, bond strength. These
test support that the design, packaging, sterilization & |
| Clinical Performance Data: | A clinical evaluation report was undertaken, supporting
that clinical testing was not necessary to support
substantial equivalence to predicate devices. |
| Substantial Equivalence summary: | Based on the comparison of the intended use, the
technological characteristics and performance data,
Hemodia S.A.S has determined that the proposed
HEMODIA ARTHROSCOPY PUMP TUBE SETS
(HATS) are substantially equivalent to the currently
marketed single use predicate devices, OrthoConcept
(FMS 4+ & disposables) K925160, FMS K954465 (FMS
DUO® + & disposables) FMS K951843 (REF. 4102CV
INTERMEDIARY TUBING, REF. 4509CV STERILE
ZONE KIT), FMS K002040 (FMS SOLO® &
disposables). HATS are tube sets that deliver irrigation
fluid both to and from the pump and to and from the
operative site during arthroscopic procedures. The
proposed devices have the same intended use, are
similar in material (including packaging material), same
sterilization method, design, function, and application to
the single use predicate devices. The device is not self-
powered but use the same energy source (pump) as the
predicate device. Performance testing demonstrates
equivalence to the predicate single use tube sets.
Hemodia included bench testing for functional
equivalence, tube set leak testing under pressure, bond
strength. These test support that the design, packaging,
sterilization & labeling of the TUBE SETS are
substantially equivalent to currently marketed single use
predicate devices. Any differences between the HATS
tube sets and the predicates single use sets are
considered minor and do not raise questions concerning
safety and effectiveness |
| | labeling of the TUBE SETS are substantially equivalent
to currently marketed single use predicate devices. |
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, black font. The text is horizontally oriented and centered. The text appears to be a header or title, possibly from a document or website.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 1, 2013
Hemodia S.A.S % Mr. Dave Yungvirt Parmalink Technical Group, LLC 20 F Street NW. Suite 700 Washington, DC 20001
Re: K132883
Trade/Device Name: HEMODIA ARTHROSCOPY PUMP TUBE SETS Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: October 14, 2013 Received: October 18, 2013
Dear Mr. Yungvirt:
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. Ilisting 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
3
Page 2 - Mr. Dave Yungvirt
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" (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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE STATEMENT
510(k) Number if known: N/A
Device Name: HEMODIA ARTHROSCOPY PUMP TUBE SETS
Indications for use:
The device intended to be used in conjunction with the FMS/Depuy/Mitek arthroscopic pump systems and delivers irrigation fluid both to and from the pump and to and from the operative site during arthroscopic procedures.
Prescription Use ✔_ Use (Per 21 CFR 801 Subpart D) Subpart C)
AND/OR
Over-the-Counter
(Per 21 CFR 807
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | Page 1 of 1 |
|---|---|
| Long H. Chen-A | for MXM |
(Division Sign-off)
| Division of Surgical Devices | Page 14 |
|---|---|
| 510(k) Number: | K132883 |