(28 days)
Not Found
No
The device description mentions a "microprocessor controlled single roller pump" and "constant performed redundant pressure control," but there is no mention of AI, ML, or related terms, nor any description of training or test data sets which are typical for AI/ML devices.
No
The device provides fluid distention and irrigation during diagnostic and operative arthroscopic procedures, which are supportive functions rather than direct therapeutic effects.
No
The device is intended for fluid distention and irrigation during arthroscopic procedures, which can be diagnostic or operative, but the device itself does not perform the diagnostic function.
No
The device description explicitly details hardware components such as a housing, power supply, roller wheel, pump head, setting keys, and display elements, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing fluid distention and irrigation during diagnostic and operative arthroscopic procedures within joint cavities. This is a direct intervention on the patient's body for surgical and diagnostic purposes, not for examining specimens in vitro (outside the body).
- Device Description: The description details a pump that physically interacts with the patient's joint cavity by delivering fluid. This is consistent with a surgical or procedural device, not an IVD which analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In summary, the Arthroscopy Pump A115 is a surgical/procedural device used during arthroscopy, not an IVD.
N/A
Intended Use / Indications for Use
The Arthroscopy Pump A115 is intended to provide fluid distention and irrigation of knee, shoulder, hip, elbow, ankle and wrist joint cavities during diagnostic and operative arthroscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
The Arthroscopy Pump A115 is a microprocessor controlled single roller pump designed to provide fluid distention and irrigation of joint cavities during diagnostic and operative arthroscopy. The pump functions according to the peristaltic principle and consists of the following main components: a housing, a peristaltic roller wheel, a pump head, various setting keys and display elements, a power supply, a rotor whose used with special designed irrigation tubings, a clemonts. The and foot pedal. A constant performed redundant pressure remove control and 1000 peonformity of the actual pressure in the joint cavity with the pre-set nominal pressure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, hip, elbow, ankle and wrist joint cavities
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No performace or clinical data is provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 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.
0
Ko 33927 1/2
'JAN 1 5 2004
510(K) SUMMARY Arthroscopic Pump A115
Submitter's Name, Address, Telephone Number, Contact Person, I. Sublishment Registration Number and Date Summary was Prepared:
W.O.M. WORLD OF MEDICINE AG Alte Poststraße 11 96337 Ludwigsstadt Germany
| Phone number: | 001 49 30 399 81 610 |
|---|---|
| FAX number: | 001 49 30 399 81 592 |
Establishment registration number: 8043980
| Contact Person: | Susanne Raab |
|---|---|
| 368 North St. Asaph Street | |
| Alexandria, VA 22314 | |
| Phone number : | 703 299 0523 |
| Fax number: | 703 299 0523 |
| Date Prepared : | Dezember 9, 2003 |
II. Device Names:
- Arthroscope and Accessories Classification Name: 1.
- Arthroscopic Pump, Tubing Sets and Common or Usual Name: 2.
- Accessory Arthroscopic Pump A115 Proprietary Name: 3.
Product Classification: III.
| Product Code: | HRX |
|---|---|
| C.F.R. Section: | 21 C.F.R. § 888.1100 |
| Device Class: | II |
Predicate Devices: IV.
- Arthroscopy Pump A107 (K030402) manufactured by W.O.M. WORLD . OF MEDICINE AG
- Arthro-Surgimat- 2000 ECU (K990443) manufactured by W.O.M. WORLD . OF MEDICINE AG
- Arthro-Surgimat-1500 (K983910) manufactured by W.O.M. WORLD OF . MEDICINE AG
1
510(K) SUMMARY Page -2- / -2-
Intended Use: V.
The Arthroscopy Pump A115 is intended to provide fluid distention and irrigation The Arthroscopy I amp Arre ankle and wrist joint cavities during diagnostic and operative arthroscopic procedures.
Device Description: VI.
The Arthroscopy Pump A115 is a microprocessor controlled single roller pump I no Arch obbopy of the micronand irrigation of joint cavities during designed to provide throscopy. The pump functions according to the thaghostic and operative anaists of the following main components: a housing, a portsuitio principler wheel, a pump head, various setting keys and display power supply, a roner whose used with special designed irrigation tubings, a clemonts. The and foot pedal. A constant performed redundant pressure remove control and 1000 peonformity of the actual pressure in the joint cavity with the pre-set nominal pressure.
Substantial Equivalence: VII.
The Arthroscopy Pump A115 described in this notification is similar in design and technological characteristics to the Arthroscopy Pump A107 (K030402), to the Arthro-Surgimat-2000 ECU (K990443) and Arthro-Surgimat-1500 (K983910) manufactured by W.O.M. WORLD OF MEDICINE AG. In addition, both the manufactured by Pump A115 and the predicate devices are intended to provide fluid distention and irrigation of knec, shoulder, hip, elbow, ankle and wrist joint cavities during diagnostic and operative arthroscopic procedures.
The differences between the Arthroscopy Pump A 1 15 and the predicate devices are minor and raise no new questions of safety and effectiveness. Accordingly, W.O.M. WORLD OF MEDICINE AG believes that the Arthroscopy Pump A 115 is substantially equivalent to the predicate devices currently on the market.
VIII. Performance/Clinical Data:
No performace or clinical data is provided.
IX. Voluntary Standards:
The device complies with the International Standard IEC 60601-1 (Flectrical Safety) and IEC 60601-1-2 (Electromagnetic Compatibility) and bears the CE mark in accordance with the Medical Device Directive 93/42/FEC.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services (HHS) in the USA. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 2004
W.O.M. World of Medicine AG c/o Ms. Susanne Raab 368 North Saint Asaph Street Alexandria, Virginia 22314
Re: K033927
Trade/Device Name: Arthroscopy Pump A115 Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope and accessories Regulatory Class: II Product Code: HRX Dated: December 16, 2003 Received: December 18, 2003
Dear Ms. Raab:
We have reviewed your Scction 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 (o 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 cither 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 docs 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 - Ms. Susanne Raab
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
fed Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATION FOR USE STATEMENT
510(k) Number (if known): KO53927
Device Name: Arthroscopy Pump A115
Indications for Use:
The Arthroscopy Pump A115 is intended to provide fluid distention and irrigation of knee, shoulder, hip, elbow, ankle and wrist joint cavities during diagnostic and operative arthroscopic procedures.
(PLFASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Sivision Sign-Oil) Division of General, Restorative and Neurological Devices
KO 33927 l (h) Nameru . .
Prescription Use
Use
(Per 21 C.F.R. 801.109)
OR
Over-The-Counter
(Optional Format 3-10-98)