(28 days)
To provide a self-locking mechanism to hold the edges of a wound open and allow for surgical exposure during general use and neurosurgical procedures.
The Harmony Port System includes the Harmony Port, which provides surgical exposure during minimally invasive procedures, along with accessory instruments designed to facilitate the use of the Port and rigidly fix the system during use.
The provided 510(k) notification summary for the Harmony™ Port System does not contain specific acceptance criteria or a study that proves the device meets such criteria. Instead, it indicates that the device's substantial equivalence to a predicate device was established through non-clinical testing.
Here's a breakdown of the information that is present and what is missing based on your requested categories:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document.
- Reported Device Performance: "The results of non-clinical testing and evaluation demonstrate that the device is safe and effective." No specific performance metrics (e.g., accuracy, precision, duration of use) are provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided. The summary only mentions "non-clinical testing," which typically refers to bench testing, mechanical testing, or simulations, rather than human data.
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 information is not applicable and not provided, as the testing was non-clinical and did not involve human-derived data that would require expert ground truthing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable and not provided, as the testing was non-clinical.
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 information is not applicable. The device is a surgical retractor, not an AI-assisted diagnostic or therapeutic device. No MRMC study was conducted or referenced.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable. The device is a physical surgical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- This information is not applicable. For non-clinical device testing, ground truth typically refers to engineering specifications, physical measurements, or established mechanical properties, rather than clinical outcomes or pathology. The document does not detail the specific "ground truth" or reference standards used for the non-clinical tests.
8. The sample size for the training set
- This information is not applicable. The device is a physical product, not a machine learning model.
9. How the ground truth for the training set was established
- This information is not applicable. The device is a physical product, not a machine learning model.
Summary of Device and Evidence:
The Harmony™ Port System is a surgical retractor intended "to provide a self-locking mechanism to hold the edges of a wound open and allow for surgical exposure during general use and neurosurgical procedures."
The basis for its 510(k) clearance (K050706) is its substantial equivalence to a predicate device, The Bright Medical Dilation Retractor System (K992898). The submission states that the Harmony Port System "has the same intended use, is manufactured from similar materials using similar processes, and is similar in design when compared to the predicate device."
The only performance data mentioned is: "The results of non-clinical testing and evaluation demonstrate that the device is safe and effective." This statement indicates that bench or mechanical tests were performed to confirm the device's functionality and safety, consistent with its classification as a Class II surgical retractor. However, no specific details about these tests, the acceptance criteria, or the reported performance metrics are provided in the excerpt.
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Page 1 of 2
APR 1 5 2005
510(k) NOTIFICATION SUMMARY
THE HARMONY™ PORT SYSTEM
| SUBMITTER: | Spinal Concepts, Inc. |
|---|---|
| ESTABLISHMENT REGISTRATIONNUMBER: | 1649384 |
| CONTACT PERSON: | Noah BartschSpecialist, Regulatory AffairsTelephone:512.533.1840Fax:512.918.2784 |
| DATE: | March 16, 2005 |
| TRADE NAME: | The Harmony™ Port System |
| COMMON NAME: | Surgical Retractor |
| CLASSIFICATION NAME: | Self-Retaining Retractor for Neurosurgery |
| CLASSIFICATION REFERENCE: | 21 CFR § 882.4800 |
| PREDICATE DEVICE: | The Bright Medical Dilation Retractor Systemmanufactured by Bright Medical Instruments,K992898, cleared October 21, 1999. |
| DEVICE DESCRIPTION: | The Harmony Port System includes the HarmonyPort, which provides surgical exposure duringminimally invasive procedures, along withaccessory instruments designed to facilitate the useof the Port and rigidly fix the system during use. |
| INDICATIONS: | To provide a self-locking mechanism to hold theedges of a wound open and allow for surgicalexposure during general use and neurosurgicalprocedures. |
| COMPARISON TO PREDICATE DEVICE: | The Harmony Port System has the same intendeduse, is manufactured from similar materials usingsimilar processes, and is similar in design whencompared to the predicate device. |
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Page 2 of 2
PERFORMANCE DATA:
.
The results of non-clinical testing and evaluation demonstrate that the device is safe and effective.
.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized symbol that resembles a bird in flight, composed of three curved lines.
Public Health Service
APR 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Noah Bartsch Specialist, Regulatory Affairs Spinal Concepts, Inc. 5301 Riata Park Court, Building F Austin, Texas 78727
Re: K050706
Trade/Device Name: Harmony™ Port System Regulation Number: 21 CFR 882.4800 Regulation Name: Self-retaining retractor for neurosurgery Regulatory Class: II Product Code: GZT Dated: March 16, 2005 Received: March 18, 2005
Dear Mr. Bartsch:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 910(t) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in intersuate for use stated in the encrosule) to regars actment date of the Medical Device Amendments, or to commence proof to May 20, 1978, the eccordance with the provisions of the Federal Food, DNAA devices that have been recalismod in aber approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require appt to the general controls provisions of the Act. The You may, incretore, market the do rec, solo, solo, so annual registration, listing of general controls provisions of the free measure reading, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is eassified (bee are ve) 2008 - 2) 2008 - 1000 - 1000 - 1000 - 100 - 100 - 100 il may be subject to such additional Segulations, Title 21, Parts 800 to 898. In addition, FDA Call be found in the Code of Feasts. East of the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination doss not mean Please be advised that IDA's issualled of a national with other requirements of the Act
that FDA has made a determination that your device complies with other made that FDA has made a decemmation in a your in the Federal agencies. You must or any receral statutes and regulations adminders, but not limited to: registration and listing (21 comply with an the Act 3 requirements) ments of the practice requirements as school in the Alastraliants as set CTK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 CFR 1800 (1950 lorin in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Mr. Noah Bartsch
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin makeemig your artial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivals and thus, nor premarket noutication. The PDA miding of backantal of an 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
s the results of the same of a comments of any and the reculation entitled If you desire specific advice for your act (240) 276-0120 . Also, please note the regulation entitled, contact the Office of Complance at (210) 276 of CFR Part 807.97). You may obtain "Misbranding by relevence to premanet noutheansment on the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-204) or and Manufacturers, International and Consumer Fibersanter at Access of Act Carling Stry/Support/index.html.
Sincerely yours,
Miriam C. Provost, Ph.D.
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Harmony™ Port System
Indications for Use:
To provide a self-locking mechanism to hold the edges of a wound open and allow for To provide a sen-locking meethallion to neeurosurgical procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this linc – Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. E. Turner
30 Edive
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Ko So7ol
§ 882.4800 Self-retaining retractor for neurosurgery.
(a)
Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.(b)
Classification. Class II (performance standards).