K Number

Device Name

MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM

Manufacturer

MEDTRONIC VASCULAR

Date Cleared

1997-03-18

(89 days)

Product Code

MAJ

Regulation Number

868.5120

Intended Use

Not Found

Device Description

Not Found

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The provided 510(k) summary contains no information about the device's technology, only anatomical sites and predicate devices. There is no mention of AI, ML, image processing, or performance studies that would indicate the use of such technologies.

Therapeutic

Yes
The presence of a predicate device that is explicitly named as "Medtronic PS Medical Algoline Intraspinal Catheter" strongly suggests a therapeutic purpose, as catheters, especially intraspinal ones, are commonly used for drug delivery or drainage in medical treatments.

Diagnostic

No
The provided information does not describe a diagnostic device. Instead, it indicates the device is a catheter used in the intraspinal space, with a predicate device identified as an "Intraspinal Catheter," which is typically an interventional or therapeutic device, not a diagnostic one.

SaMD (Software as a Medical Device)

Unknown

The provided 510(k) summary is incomplete and lacks crucial information about the device description and intended use, making it impossible to determine if it is a software-only medical device. The anatomical sites mentioned (intraspinal, subcutaneous tissue, etc.) suggest a physical component, but without a device description, this is speculative.

IVD (In Vitro Diagnostic)

Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic).

Here's why:

Anatomical Site: The anatomical sites listed (Intraspinal, subcutaneous tissue, cerebrospinal fluid (CSF), spinal cord, lumbar, CNS, epidural, subarachnoid space) are all related to the human body and its internal structures. IVDs typically analyze samples taken from the body (like blood, urine, tissue biopsies) in vitro (outside the body).
Predicate Device: The predicate device listed (Medtronic PS Medical Algoline Intraspinal Catheter) is a medical device used for delivering substances into the spinal area. This is consistent with a device that interacts directly with the body, not one that analyzes samples in vitro.
Lack of IVD-Specific Information: The document lacks any information typically associated with IVDs, such as:
- Intended Use/Indications for Use that describe analyzing samples.
- Device Description that mentions reagents, assays, or analytical methods.
- Performance studies related to analytical accuracy or precision of sample analysis.

Conclusion:

The information strongly suggests this device is a medical device intended for use within the body, likely for delivery or access to the spinal area, rather than an IVD which analyzes samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Not Found

Product codes (comma separated list FDA assigned to the subject device)

Not Found

Device Description

Not Found

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

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.

Not Found

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

Regulation Number and Section

§ 868.5120 Anesthesia conduction catheter.

(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).

Summary

MAR 1 8 1997

14 965251 ; Medtromic PS Medical Algoline Intraspinal Cotheter

SUMMARY OF SAFETY AND EFFECTIVENESS PROBLEMS ASSOCIATED WITH INTRASPINAL CATHETERS (ADVERSE EFFECTS)

The adverse effects associated with the use of the AlgoLine Intraspinal Catheter System may include, but may not be limited to, the following.

Catheter Complications

Change in catheter performance, due to kinking, disconnection, leakage, breakage, complete or partial occlusion, dislodgement or migration, or fibrosis or hygroma, which can result in:

delivery of drug into the subcutaneous tissue, .
drug withdrawal symptoms, �
return of underlying symptoms, ●
free-floating catheter in the cerebrospinal fluid (CSF), .
. underinfusion of the drug,
CSF leak leading to spinal headache, CSF subcutaneous collection, or rare CNS . pressure-related problems,
damage to the spinal cord, or .
surgical replacement / revision of the catheter. .

Drug Complications

Local and systemic drug toxicity and related side effects .
Complications due to use of untested drugs with the system .
Complications due to using drugs not in accordance with the drug labeling .

Procedural (Surgical) Complications

Lumbar puncture-type headache .
CSF leak leading to spinal headache, CSF subcutaneous collection, or rare CNS � pressure-related problems
Radiculitis .
Arachnoiditis .
Bleeding .
Damage to the spinal cord .
Meningitis ●
Spinal headache .
Medical complications �
Complications from anesthesia .
Damage to the catheter due to improper handling .

Other

Allergic or immune system response to the implanted materials .
Body rejection phenomena ●
Complications due to the interaction of the catheter with unusual physiological . variations in patients
Surgical replacement of the catheter due to complications ●
Complications due to other intervening acts ◆

PRODUCT COMPLAINT HISTORY

Approximately 5,000 AlgoLine intraspinal catheters of various models and designs have been distributed worldwide. As of January 15, 1997, the complaint history consists of a total of nine complaints involving 12 catheters reported. These complaints have included:

(3 ea) Catheter fracture
(3 ea) Catheter leakage
(2 ea) Strain relief missing from package (involving 5 packages)
(1 ea) Tuohy needle broke during use

BIBLIOGRAPHY

Brant JM. The use of access devices in cancer pain control. Seminars in Oncology 1. Nursing 11:203-212, 1995.
Chabal C, RP Buckley, L Jacobson, L Butler and T Murphy. Long term epidural 2. morphine in the treatment of cancer pain. The Pain Clinic 3:19-23, 1989.
de Champs C, D Guelon, D Joyon, D Sirot, M Chanal and J Sirot. Treatment of a 3. meningitis due to an Enterobacter aerogenes producing a derepressed cephalosporinase and a Klebsiella pneumoniae producing an extended-spectrum B-lactamase. Infection (Germany) 19:181-183, 1991.
Crul BJ and EM Delhaas. Technical complications during long-term subarachnoid 4. or epidural administration of morphine in terminally ill cancer patients: a review of 140 cases. Reg Anesth 16:209-213, 1991.
DuPen SL, DG Peterson, AJ Bogosian, DH Ramsey, C Larson-and-M Omoto. A റ്റ് new permanent exteriorized epidural catheter for narcotic self-administration to control cancer pain. Cancer 59:986-993, 1987.
DuPen SL. DG Peterson, A Williams, DH Ramsey, and AJ Bogosian. Infection 6. during chronic epidural catheterization: diagnosis and treatment. Anesthesiology 73:906-909, 1990
Krames ES. Intrathecal infusional therapies for intractable pain: patient 7. management guidelines. Journal of Pain and Symptom Management 8:36-46, 1993.
Lamer TJ. Treatment of cancer-related pain: when orally administered medications 8. fail. Mayo Clin Proc 69:473-480, 1994.
Lubenow TR and AD Ivankovich. Intraspinal narcotics for treatment of cancer pain. ರು. Seminars in Surgical Oncology 6:173-176, 1990.
Mercadante S. Intrathecal morphine and bupivacaine in advanced cancer pain 10. patients implanted at home. Journal of Pain and Symptom Management 9:201-207, 1994.

Nitescu P, M Sjoberg, L Appelgren and I Curelaru. Complications of intrathecal 11. opioids and bupivacaine in the treatment of "refractory" cancer pain. The Clinical Journal of Pain 11:45-62, 1995.
1. Nitescu P, L Appelgren, E Hultman, L-E Linder, M Sjoberg and I Curelaru. Longterm, open catheterization of the spinal subarachnoid space for continuous infusion of narcotic and bupivacaine in patients with "refractory" cancer pain. The Clinical Journal of Pain 7:143-161, 1991.
Sjoberg M, P Nitescu, L Appelgren and 1 Curelaru. Long-term intrathecal morphine 13. and bupivacaine in patients with refractory cancer pain. Anesthesiology 80:284-297, 1994.
Stamer U and C Maier. Epidural opiates: cancer pain management in outpatients. 14. (Abstract) Anaesthesist 41:288-296, 1992.
Wagemans MFM, EM Spoelder, WWA Zuurmond and JJ De Lange. Continuous 15. intrathecal analgesia in terminal cancer patients within transmural health care. Ned Tijdschr Geneeskd (Netherlands) 137:1553-1557, 1993.
1. Waldman SE, GS Feldstein, ML Allen and G Turnage. Selection of patients for implantable intraspinal narcotic deliver systems. International Anesthesia Research Society. 1986.