(49 days)
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.
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.
The provided document describes the HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) and asserts their substantial equivalence to predicate devices. The document does not describe a study involving an AI/Machine Learning device, human readers, or the establishment of ground truth in the way anticipated by the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI performance.
Instead, this document pertains to a 510(k) submission for a medical device that is a pump tube set for arthroscopic procedures, not an AI or diagnostic imaging device. Therefore, many of the requested fields are not applicable.
Here's the information derived from the provided text, with an explanation of why certain fields are not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstration of Equivalence) | Reported Device Performance (HEMODIA ARTHROSCOPY PUMP TUBE SETS) |
|---|---|
| Technological Characteristics: Similar in material (including packaging material), design, function, and application to single-use predicate devices. Not self-powered, uses the same energy source (pumps) as predicate devices. | 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 (Bench Testing): Functional equivalence, tube set leak testing under pressure, bond strength. Support that design, packaging, sterilization, and labeling are substantially equivalent to currently marketed single-use predicate devices. | 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 tests support that the design, packaging, sterilization & labeling of the TUBE SETS are substantially equivalent to currently marketed single use predicate devices. |
| Clinical Performance Data: Not explicitly stated as a general acceptance criterion, but the report justifies why clinical testing was not necessary. | A clinical evaluation report was undertaken, supporting that clinical testing was not necessary to support substantial equivalence to predicate devices. |
| Intended Use: Same as predicate devices. | The proposed devices have the same intended use (delivers irrigation fluid to and from the pump and operative site during arthroscopic procedures when used with specific FMS/Depuy/Mitek arthroscopic pump systems). |
| Overall Equivalence: Differences between the HATS tube sets and the predicates single-use sets are minor and do not raise questions concerning safety and effectiveness. | 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. 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. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This device is a physical medical device (pump tube set), not an AI or diagnostic device that uses a "test set" of data in the common understanding of AI/ML performance evaluation. The "testing" referred to is bench testing (e.g., leak testing, bond strength), not a dataset of patient cases. Thus, this question is not applicable in the context of the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable as the device is not an AI or diagnostic imaging device that requires radiologist or medical expert interpretation of a "test set" for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for the reasons stated above.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable as the device is not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to AI performance (e.g., disease presence) is not relevant here. The "truth" or acceptance of the device's performance is based on meeting engineering and functional specifications during bench testing (e.g., no leaks under pressure, sufficient bond strength, functional equivalence to predicate devices).
8. The sample size for the training set
This question is not applicable as the device is not an AI or machine learning device requiring a training set.
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated above.
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5. 510(K) SUMMARY
HEMODIA ARTHROSCOPY PUMP TUBE SETS - 510(k) Summary
| OWNER: | Hemodia S.A.S.85 du Chêne Vert, 31670 Labège FRANCETel: +33 5 61 00 71 81 - Fax: +33 5 61 00 47 40remi.teuliere@hemoda.com |
|---|---|
| Contact: | Mr. Rene van de Zande, President & CEOEmergo Group, Inc.Phone: 512.327.9997 Fax: 512.327.9998usagent@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 888.110087 OrthopedicProduct Code: HRX |
| Equivalent Device(s): | OrthoConcept (FMS 4+ & disposables) K925160 FMS K954465 (FMS DUO ® + & disposables) FMS K951843 (REF. 4102CV INTERMEDIARYTUBING, 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 toand from the pump and to and from the operative siteduring arthroscopic procedures. |
| Intended and Indicationsfor Use: | The device intended to be used in conjunction with theFMS/Depuy/Mitek arthroscopic pump systems anddelivers both irrigation fluid to and from the pump and toand from the operative site during arthroscopicprocedures. |
| TechnologicalCharacteristics | The TUBE SETS are similar in material (includingpackaging material), design, function, and application tothe single use predicate devices. The device is not self-powered but uses the same energy source (pumps) asthe predicate devices. The technological characteristicsare the same as the predicate device. |
| Performance Data: | Performance testing was performed to demonstrateequivalence to the tube sets not the hardwarereferenced in the predicate devices. Hemodia's testingincluded bench testing for functional equivalence, tubeset leak testing under pressure, bond strength. Thesetest support that the design, packaging, sterilization & |
| Clinical Performance Data: | A clinical evaluation report was undertaken, supportingthat clinical testing was not necessary to supportsubstantial equivalence to predicate devices. |
| Substantial Equivalence summary: | Based on the comparison of the intended use, thetechnological characteristics and performance data,Hemodia S.A.S has determined that the proposedHEMODIA ARTHROSCOPY PUMP TUBE SETS(HATS) are substantially equivalent to the currentlymarketed single use predicate devices, OrthoConcept(FMS 4+ & disposables) K925160, FMS K954465 (FMSDUO® + & disposables) FMS K951843 (REF. 4102CVINTERMEDIARY TUBING, REF. 4509CV STERILEZONE KIT), FMS K002040 (FMS SOLO® &disposables). HATS are tube sets that deliver irrigationfluid both to and from the pump and to and from theoperative site during arthroscopic procedures. Theproposed devices have the same intended use, aresimilar in material (including packaging material), samesterilization method, design, function, and application tothe single use predicate devices. The device is not self-powered but use the same energy source (pump) as thepredicate device. Performance testing demonstratesequivalence to the predicate single use tube sets.Hemodia included bench testing for functionalequivalence, tube set leak testing under pressure, bondstrength. These test support that the design, packaging,sterilization & labeling of the TUBE SETS aresubstantially equivalent to currently marketed single usepredicate devices. Any differences between the HATStube sets and the predicates single use sets areconsidered minor and do not raise questions concerningsafety and effectiveness |
| labeling of the TUBE SETS are substantially equivalentto currently marketed single use predicate devices. |
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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
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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 |
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| Long H. Chen-A | for MXM |
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| Division of Surgical Devices | Page 14 |
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| 510(k) Number: | K132883 |
§ 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.